3.1. Globally 466 million people have disabling hearing loss; this number is expected to double by 2050 due to ageing populations, and new cases of hearing loss caused by untreated ear infections, ototoxicity, and noise exposure.

Hearing loss that prevents hearing at thresholds lower than 40 decibels (d.B.) in the better hearing ear in adults and lower than 30 d.B. in the better hearing ear in children is known as disabling hearing loss. 4 More than 5% of the global population—or 466 million people—have disabling hearing loss, with 34 million of these being children. 5 It is the fourth leading cause of disability globally. 6 Approximately 90% of people with hearing loss live in low- and middle-income countries (L.M.I.C.s) with prevalence rates almost four times that of high-income regions. 7

Multiple causes for hearing loss exist, but they can primarily be placed into two categories: congenital and acquired factors. Congenital causes include genetic causes and complications due to pregnancy or childbirth such as maternal infections (especially congenital syphilis), birth asphyxia, exposure to certain drugs during pregnancy, and low birth weight or jaundice. It is estimated that five out of every 1,000 babies are born with hearing loss or acquire it soon after birth in one or both ears. Acquired causes can occur at any age and include infectious diseases, such as mumps, measles or rubella, chronic ear infections, use of ototoxic medicines (i.e. medicines known to damage cells in the ear), injury, noise exposure, and blockages in the ear canal. 8 Untreated infections, ototoxicity and ear blockages are the primary factors for hearing loss in L.M.I.C.s.

The number of people with disabling hearing loss is expected to double to 900 million people by 2050, 9 driven by:

• POPULATION GROWTH AND AGEINGDisabling hearing loss is associated with ageing; approximately one-third of people over 65 years of age are affected by disabling hearing loss . 10 and as the population increases from 7.5 billion people 11 in 2017 to 10 billion in 2050 12 , the world's population over 65 years of age is expected to double to 1.5 billion. 13
• NOISE EXPOSURENoise exposure can come from occupational environments, entertainment venues, and personal listening devices. The W.H.O. estimates that 1 billion young people are at risk of hearing loss due to listening practices. . 6
• UNTREATED EAR INFECTIONS.Inability of health systems to identify and treat incident and chronic ear infections will result in an additional 16.5 million people developing hearing loss each year. 14
• OTOTOXICITY. Certain classes of drugs, such as some used in the treatment of neonatal infections, malaria, drug-resistant tuberculosis (T.B.) and cancers, have ototoxic side effects that can result in hearing loss (refer to Case Study 1).

3.2. W.H.O. estimates that 72 million people worldwide need hearing aids, but current coverage of hearing aids meets less than 3% of need in L.M.I.C.s. 16

A hearing aid is a rehabilitative device that amplifies sound frequencies for those with hearing impairment. Not all people with hearing loss will require or benefit from a hearing aid. Appropriateness of hearing aid use for an individual is dependent on the type (conductive or sensorineural; Table 1) 17 and severity 18 (mild to profound; Table 2) of hearing loss. 19 Hearing aids support improvement for varying degrees of hearing loss from mild to severe sensorineural hearing loss, which is caused by damage to the small sensory cells in the inner ear.

TABLE 1: HEARING LOSS BY TYPE

TABLE 2: HEARING LOSS BY SEVERITY

W.H.O. estimates that more than 72 million people worldwide would benefit from the use of hearing aids, but only 10% of those that need it have it, with coverage at less than 3% in L.M.I.C.s. 20 This estimate is based on limited data and is considered by many experts to be an underestimate. The forthcoming World Hearing Report, which is expected to be published in 2020 by the W.H.O., will provide updated estimates of need.

Not all individuals with severe to profound sensorineural hearing loss will benefit from a hearing aid. When hearing aids are insufficient or do not provide expected benefit and in select circumstances, cochlear implants may be recommended. A cochlear implant is a medical device that consists of an external portion that sits behind the ear and an internal portion that consists of an electrode array and receiver/stimulator that must be surgically implanted. A cochlear implant bypasses the damaged portions of the ear to deliver sound signals directly to the auditory nerve. Hearing via a cochlear implant takes time to learn or relearn. While an important assistive technology, cochlear implants will not be a focus of this product narrative as they only benefit a tiny fraction of the population (less than 50,000 cochlear implants are sold globally each year) and are currently prohibitively expensive for L.M.I.C.s with costs for the device and surgery ranging from $40,000 to $100,000 per implant, require complex surgical and audiological care that is often not available in L.M.I.C.s yet..

For people with conductive hearing loss, for which hearing aids are not appropriate, medical treatments, such as antibiotic therapy or earwax removal performed by primary care healthcare workers or primary care physicians, or surgical treatments performed by Ear, Nose and Throat (E.N.T.) surgeons, may help resolve hearing issues. For example, W.H.O. estimates that 330 million of the 466 million people with disabling hearing loss suffer from chronic ear infections or chronic otitis media, 21 which can be resolved medically. Once the conductive hearing loss has been resolved, patients may require a hearing aid in case of sustained damage to the ear.

3.3. Unaddressed hearing loss has a profound effect on individuals, and hearing aids can assist to counteract negative effects.

Studies show that quality of life is significantly lower among people with hearing loss, and people with hearing loss tend to secure lower rates of employment. Additionally, W.H.O. estimates that unaddressed hearing loss poses an annual global cost of U.S.$750 billion with a negative impact on education, social life and employability of those with hearing loss. 22 Negative outcomes associated with hearing loss can be attributed primarily to three factors: 23

• LEARNING. In children, hearing loss can adversely affect speech acquisition, learning, and academic performance. In L.M.I.C.s, children with hearing loss may not receive schooling, which may contribute to unemployment later in life. It is important to identify children with hearing loss early and provide rehabilitative support. In most H.I.C.s, newborn hearing screening is the standard of care. In the U.K., for example, newborn hearing screening has coverage rates as high as 99%. In many L.M.I.C.s, newborn hearing screening is not routine. W.H.O. recommends that newborns identified with hearing loss start using hearing aids, combined with rehabilitation services, from the age of 3 months to support speech and language development.
• SOCIAL.The inability to communicate with others can have an adverse social and emotional impact due to loneliness, isolation and frustration. A study in Nigeria concluded that elderly people with hearing loss have higher rates of depression, reducing their interesting in daily activities, with 62% reporting depression symptoms as opposed to 17% for those without hearing loss. 24
• HEALTH.Loss of hearing can increase the incidence of dementia, among other comorbidities such as falls. 25 One study suggests that individuals with hearing loss have a two to five times higher risk of dementia, depending on severity, than those with normal hearing. 26 Hearing loss is also associated with accelerated cognitive decline among older adults. 27

Hearing aids can have a transformative impact on reducing the negative outcomes of hearing loss. A study conducted by World Wide Hearing (W.W.H.) and Sonrisas que Eschuchan Foundation in Guatemala in 2016 assessed the positive impact of hearing aids among 180 people with moderate to profound hearing loss. In less than a year of usage, the study found that 56% reported improved ability to communicate with family and friends and 88% reported that hearing aids had positively changed their enjoyment of life. 28

CASE STUDY 2: A USER'S EXPERIENCE WITH HEARING AIDS 29

Shine, a 3-year-old girl, had her first hearing assessment in November 2017 in Lusaka, Zambia when her mother brought her to the clinic due to delayed speech but was not aware that this was the result of hearing loss. Shine was tested using play audiometry (a technique used to test the hearing of young children to respond to sounds as part of a game), which confirmed that she has severe sensorineural hearing loss in both ears. After impressions of her ears were taken to make a custom earmould, Shine was fitted with hearing aids. Shine's mother was taught how to use hearing aids. In a follow-up appointment, the audiologist noted that Shine had been wearing hearing aids for 11 hours per day and additional tests confirmed that she was benefitting from the hearing aids.

3.4. Experts recommend that hearing aids should be provided within the context of a broader Ear and Hearing Care programme, but multiple implementation challenges exist.

Hearing aids are only one component of a comprehensive service delivery and rehabilitation model, known as Ear and Hearing Care (E.H.C.), which is required to effectively identify and address pathologies of the ear. The W.H.O. promotes E.H.C. programmes and strategies. Services are required across all levels of a health system, from the community to the hospital level. Each health level would involve activities from prevention and raising awareness to screening and detection to treatment and rehabilitation (refer to Appendix B. for detailed activities to be provided at each level of the health system).

Beyond general health system constraints, multiple challenges associated with the implementation of E.H.C. in L.M.I.C.s exist, including:

• LACK OF A NATIONAL OR SUB-NATIONAL E.H.C. STRATEGY.A W.H.O. multi-country assessment published in 2013 reported that of the 46 L.M.I.C.s that participated, 41% did not have a national or subnational strategy for E.H.C.. 30
• LACK OF PLANNING AND BUDGETING FOR SERVICES, including required equipment, human resources and products. In the same W.H.O. assessment, countries cited lack of financial resources and lack of human resources as the primary reason for not having developed a national program. Competing health priorities and insufficient political will were also noted. 31
• LACK OF TRAINED HEALTH WORKERS, including audiologists and E.N.T. surgeons at all levels. Many countries require that hearing loss diagnosis and hearing aid fitting only be conducted by audiologists or E.N.T. surgeons. L.M.I.C.s generally have a shortage of audiologists—who typically need two years of post-graduate coursework—which limits the ability to scale services. Only six out of 37 low and lower-middle-income countries had more than one audiologist per 1 million people compared to 17 out of 20 upper-middle- and high-income countries. 32 The low availability of audiologists can partly be attributed to the migration of many audiologists to higher income countries. For example, approximately 50% of Indian audiologists are estimated to have relocated to other nations. 33
• LACK OF TRAINING TO SUPPORT TASK SHIFTING. While training models are available for E.H.C. from the W.H.O., there are no training modules available specifically for hearing aid provision; therefore, N.G.O.s have trained community health workers, nurses and audiology technicians by creating their own training modules to provide hearing care services.

CASE STUDY 3: DEVELOPING E.H.C. STRATEGIES IN AFRICA

As most countries in East and Central Africa lack financial resources to develop national E.H.C. strategies, Starkey Hearing Foundation, the German Federal Ministry of Economic Cooperation and Development (B.M.Z.) and C.B.M. have funded the East and Central Africa E.H.C. Forum, an advocacy group created by independent audiologists and E.N.T. surgeons in 2016. The forum is advocating that all countries in the region develop national plans for E.H.C. by end of 2019. These partners and the forum have advocated for and/or have supported the development of national plans for E.H.C. in the following countries: Burundi, Democratic Republic of Congo, Ethiopia, Kenya, Madagascar, Malawi, Nigeria, Rwanda, Tanzania, Uganda, Zimbabwe, and Zambia.

3.5. Provision of hearing aids generally includes the following steps: 1) screening for and diagnosing hearing loss; 2) selecting and fitting appropriate hearing aids; and 3) providing long-term follow-up and rehabilitation services to the user.

FIGURE 2: SAMPLE AUDIOGRAM

Image Description

Sample of an Audiogram. This is a line chart comparing the left and right ear, with hearing levels rated as Normal, Minor hearing loss, Moderate hearing loss, Severe hearing loss and Profound hearing loss. Audiometry uses specialized equipment, called an AudioMeter, to develop an audiogram which describes the hearing loss in terms of volumes (y-axis) across various frequencies (x-axis).

The continuum of care includes the following high-level steps:

1. SCREENING AND DIAGNOSIS. Hearing aid provision begins with case finding and screening for hearing loss or an individual presenting for hearing evaluation. A provider then examines the ear with an otoscope to rule out conductive causes. This is followed by diagnostic testing using audiometry to determine the severity of the hearing loss and if a hearing aid is appropriate. Audiometry uses specialised equipment, called an audiometer, to develop an audiogram (Figure 2), which describes the hearing loss in terms of volumes (y.-axis) across various frequencies (x.-axis).
2. FITTING OF HEARING AID. Once a person has been determined to have hearing loss that can be addressed via a hearing aid and rehabilitation services, the appropriate hearing aid (one that is a good match for severity of hearing loss and takes into account a person's perceptual difficulties) is selected and fitted, whereby a trained professional uses a computer programme to match the audiogram to the appropriate amplification curve of the hearing aid and adjusts based on the user's feedback and potential additional testing. The fitting visit should include fitting, programming, verification, instructions on use, and counselling.
3. REHABILITATION. Rehabilitation services begin at the first fitting when the user is provided guidance and counselling on hearing aid usage. Additional adjustments are made over time to respond to the user's experience. Audiological rehabilitation or peer support may be used to instruct the user in hearing aid management and use as well as on how to adjust to the use of a hearing aid and increase skills related to hearing and speech. This counselling may be carried out in-person or via home-based exercises, e-mail and/or phone calls.
4. AFTER-CARE. Aftercare includes the maintenance and repairs of hearing aids, as well as battery and earmould management. Batteries must be available and replaced regularly, while earmoulds may be replaced every 6-12 months to 3 years depending on age.

Appendix C provides a more detailed description of the hearing aid continuum of care including screening, diagnosis, fitting, and rehabilitation and after-care.

Provision of hearing aids requires earmoulds and batteries over the life of the hearing aid:

• EARMOULDS. Usually made of medical-grade plastic or silicone, earmoulds are custom-made so that they sit comfortably within the user's ear canal, preventing feedback loop, a high-pitched whistling that is caused when the amplified sound leaks out and is re-amplified. The process to develop custom-made earmoulds requires specialised equipment and materials, adding to the supply chain complexity of hearing aids and time required for service provision and fitting. In most places, earmould impressions are sent to a lab where a trained technician develops the mould. This can add additional waiting time and requires follow-up visits to the clinic, which may limit access. Furthermore, earmoulds typically last 2-3 years for adults and 6-12 months among children and hence need to be made consistently available to ensure long-term usage. The medical-grade silicone or plastic is often unavailable locally and must be imported. Experts suggest that earmoulds in L.M.I.C.s cost ~U.S.$5-8.

• EARDOMES.Many experts suggest the use of eardomes instead of earmoulds as a way to increase access, as they are factory made and do not require customisation (refer to Figure 3); however, they cannot be used for all users due to acoustic ventilation that can cause negative feedback loop or loss of amplification. Eardomes come in multiple sizes and the user can pick the one that is most comfortable. The cost of these eardomes is significantly lower than a custom earmould (< U.S.$0.10). 34

  FIGURE 3: EARMOULDS AND EARDOMES

  Earmoulds	Eardomes

• BATTERIES. Access to a continuous supply of batteries is critical to ensure continued use as hearing aid batteries deplete on average every 5-10 days depending on the processing power and features of the hearing aid. Sizes of hearing aid batteries are developed for and unique to hearing aids; therefore, they are often not locally available in L.M.I.C.s. Hearing aid batteries cost between U.S.$0.17 – U.S.$0.38 per battery across both L.M.I.C. and H.I.C. markets, which translates to about U.S.$12 – U.S.$50 per year in battery costs depending on depletion rate. Experts suggest that rechargeable batteries are far more cost-prohibitive at the moment and make limited sense for hearing aids that must be worn for the majority of the day.

3.6. W.H.O. global guidelines related to hearing aid provision in low-resource settings (L.R.S.) are outdated and lack specificity, which has led to a variety of approaches to hearing aid provision.

W.H.O. developed the “Guidelines for Hearing Aids and Services for Developing Countries” 35 in 2004. Since hearing aid provision should happen in the context of E.H.C., W.H.O. supplemented these guidelines with the “Primary Ear and Hearing Care Training Resources” 36 in 2012 and with the “Preferred profile for hearing 12 aid technology suitable for L.M.I.C.s” in 2017 (henceforth referred to as the W.H.O. Preferred Product Profile or W.H.O. P.P.P.—refer to Appendix D.). 37

The 2004 Guidelines lack specificity on personnel, provision and product:

• PERSONNEL. There is limited guidance on who is allowed to provide hearing aids and what the standards are for their training, accreditation, and long-term skills building. Some countries have very restrictive policies that require licensed audiologists or E.N.T. surgeons to provide hearing aids and as a result curtail general access to this service, while others have limited regulation, which may lead to substandard service.
• PROVISION. Although new technologies (refer to section 4.10) for the detection and diagnosis of hearing loss exist, it is unclear how these may change the guidelines for provision and how they compare to existing audiometry technology. There is also limited guidance on the provision of earmoulds using the latest technology.
• PRODUCTS. Although the W.H.O. P.P.P. provides transparency on the desired product specifications for hearing aids, there remains contention among experts about the appropriateness of digital hearing aids that are manually programmable (“trimmer-based”) versus those that are software programmable. New classes of hearing aid products (refer to section 4.11) such as self-programmable, pre-programmable, and over-the-counter are mentioned, but there is no clear guidance, largely due to lack of evidence.

These also do not incorporate guidance on the latest advancements in technologies for screening and fitting earmoulds or hearing aids (discussed in section 4.12). Lastly, specific training resources for hearing aid provision in L.R.S. are limited. While audiologists and others in the sector may disagree on technical aspects of service delivery, there is a consensus that delivery must avail the use of audiometry, ensure appropriate fitting, and be provided in a context where long-term support is available. This consensus has been captured in the voluntary development of some guidelines and standards, such as the forthcoming “Suggested Guidelines for Humanitarian Hearing Care Outreach Programs” developed by the Coalition for Global Hearing Health. 38

While plans to update the W.H.O. Guidelines or the W.H.O. P.P.P. do not currently exists, the W.H.O. is open to developing new target service delivery profiles and product profiles through a consensus process with the hearing community.

3.7. While different types of hearing aids exist in the market, specific hearing aids appropriate for the L.M.I.C. context are described by the W.H.O. P.P.P..

Hearing aids are not one size fits all, and are differentiated by amplification power (the more severe the hearing loss, the higher the amplification power required), amplification technology (analogue vs. digital), sound processing capabilities, style (refer to Table 3 on hearing aid styles), battery types used, and special features (such as Bluetooth, Artificial Intelligence, etc.). Telecoil facility and compatibility 39 , direct audio input, directional microphones, etc. are also important functions of hearing aids that are necessary for long-term optimal use in various settings.

TABLE 3: EXAMPLES OF HEARING AID STYLES 40

BODY WORN	BEHIND-THE-EAR (B.T.E.) W.H.O. P.P.P. recommended	RECEIVER-IN-CANAL (R.I.C.)	IN-THE-EAR	COMPLETELY-IN-THE-CANAL/INVISIBLE-IN-THE-CANAL
Least complex hearing aids that can be worn on the user's body with earbuds placed in the ear.	The technology is housed in a casing that rests behind the ear and a plastic, acoustical tube directs sound into an earbud or custom earmould.	R.I.C.s are a subset of B.T.E. hearing aids where the receiver of the hearing aid is inside the ear canal.	Custom designed hearing aids that are complex to fit and require significant care. They are visible as they sit on the outer ear of the user.	Custom made to fit completely in the ear canal with only a small plastic ‘handle’ on the outside for removing it when not in use.

The W.H.O. P.P.P. recommends Behind-the-Ear (B.T.E.) hearing aids as the primary choice for public health distribution in L.M.I.C. as it has the widest coverage range for severity levels and is the easiest to fit among current styles.

Many hearing aids are able to serve multiple levels of severity, but not all levels. Table 4 provides rough estimates of the mix of devices that would be required to meet the needs of a population. However, the W.H.O. P.P.P. does not specify the mix of products, based on amplification power of user needs that should be procured by hearing programs or procurement agents to meet the population's needs. Hearing aids should be selected to meet the amplification and perceptive needs of the user. The P.P.P. is also limited by the fact that it does not outline a target price for the total cost of ownership over the lifetime of the product nor does it support additional technical guidance for procurement. Additional limitations are covered in the next section on quality.

TABLE 4: ROUGH ESTIMATION OF THE PROPORTION OF DEVICES NEEDED IN L.M.I.C.S 41

3.8. No global standard for quality testing currently exists to differentiate quality hearing aids from poor quality products.

Measures of hearing aid quality should encompass a number of domains including sound quality, consistency of the audio output, durability, comfort for the user, moisture and dust resistance, and usability and effectiveness of the software programming interface. However, there is currently no single set of standards that allow for the differentiation between quality and lower or non-quality products.

Quality of hearing aids affects the user experience; poor sound quality, discomfort, or unreliability can lead to low usage rates or discontinuation. This limits the benefit that the user can derive from the hearing aids and makes it less likely that they will persevere until they find a quality product that works well. In addition, a poorer quality hearing aid can over-amplify some sounds, contributing to hearing damage. Lastly, while many products that are considered by experts as high quality meet moisture and dust resistant standards (such as I.P.67 42 , 43 ), they are still not well-suited for L.M.I.C. climates, which tend to be harsher than H.I.C. climates, and can often breakdown or get damaged quickly if not well protected.

The W.H.O. P.P.P. provides some guidance on aspects of quality but is not designed to be a rigorous quality standard. Many products match the W.H.O. P.P.P. on paper, but in practice have poor sound quality, are not durable, or are difficult to program by the provider. Unfortunately, there are no existing or planned standards for hearing aids that provide an objective measure of quality to inform procurement for low-resource settings. 44 According to experts, the U.S. F.D.A. and C.E. marks are not able to differentiate quality from non-quality products on the measure of hearing quality outlined above, and there is no globally recognised quality-testing programme. The F.D.A. requires certification of gains and output of hearing aids through a third party agency to ensure they match specifications but that is not a certification of quality. 45 While W.H.O.'s forthcoming Assistive Product Specifications (A.P.S.) will providing further clarity to procurers, they will not serve as an established quality standard.

In the absence of objective quality standards, private providers are loyal to certain manufacturers where they and their clients have had positive experiences with specific products, typically one of the leading global manufacturers. To maintain brand reputation, these manufacturers rigorously enforce internal quality standards. In seeking lower-cost alternatives, audiologists may conduct a “field test” of products, by having users try them for a certain period and then reporting their experiences with the products. The results of these tests are rarely published. 46 This leaves procurers without guidance on which hearing aids are of high quality and they often award contracts for hearing aids to the lowest bidder.

3.9. Donor funding for procurement and provision of hearing aids in L.M.I.C.s is limited and often comes from C.S.R. programmes of leading suppliers.

The donor landscape in hearing aids is limited and fragmented with most funding for N.G.O.s coming from corporate social responsibility (C.S.R.) initiatives. There is no one bilateral donor that is heavily engaged in the hearing space; however, Canada Grand Challenges, G.I.Z., and others have provided limited grant support to N.G.O.s and social enterprises, often through wider disability programmes, around the development of innovations in hearing screening and care, provision of hearing aids, and support of E.H.C. strategies.

Three of the five leading suppliers of hearing aids have set up foundations to channel their philanthropic support: Hear the World Foundation (Sonova); Oticon Foundation (William Demant) and Starkey Foundation (Starkey). These foundations support both in-kind donation of new and refurbished product as well as grants to N.G.O.s.

The Starkey Foundation is the largest donor of hearing aids globally with ~100,000 units donated per year. Starkey Foundation organises and runs community-based hearing programs that include patient identification, hearing aid missions or community camps to fit hearing aids, and aftercare programs in partnership with governments or N.G.O.s. Starkey Foundation hearing missions utilise mostly refurbished, donated hearing aids.

Most N.G.O.s rely on individual donations, corporate donation matching schemes and support from C.S.R. initiatives, such as those from leading supplier to fund their hearing aid screening and provision activities.

4.1. The global hearing aids market focuses on high-income markets and is consolidated around five major manufacturers who control the value chain.

The global market for hearing aids is valued at U.S.$6 billion with more than 16 million hearing aids sold annually. 47 The market expects unit growth of 3% to 5% every year with 70% of units sold in Europe and North America. 48

The five largest manufacturers control more than 90% of the market. Leading global players, henceforth referred to as the ‘Big 5’, are: Sonova (Switzerland), W.S. Audiology (Singapore), William Demant (Denmark), G.N. Resound (Denmark), and Starkey (U.S.A.). Annual statements of two leading manufacturers suggest that these companies have earnings (before interest and taxes) margins of around 25% and gross margins of around 70-80%. Sales and marketing is the biggest cost driver and typically accounts for 40% of the cost. Acquisitions of smaller promising companies by the Big 5 keeps the market consolidated. The Big 5 players have multiple brands and subsidiaries whose products differ in features and price (anywhere from ~$600 to over $3000 per unit for high-end models), allowing them to capture different market segments. These holdings are the result of both in-house product development and acquisitions.

In H.I.C.s, products and services are often bundled to the end user. The Big 5 hold considerable control over the value chain in H.I.C.s in order to maximise returns to the company and protect market shares. They do this via:

• EXCLUSIVE CONTRACTS WITH AUDIOLOGISTS. The Big 5 have strong bargaining power with audiologists and can leverage exclusive contracts with them in exchange for discounted pricing.
• TECHNICAL HURDLES TO SWITCHING MANUFACTURERS. Each supplier has its own proprietary fitting software, complicating the learning process for audiologists when they to shift to another supplier.

In the United States and other H.I.C.s, hearing aids are sold wholesale to retailers and audiologists for around U.S.$300-600. The retailers and audiologists then add a service price between U.S.$1,900-2,100 per hearing aid, which includes professional fitting and after-care services. Bundled prices to users in H.I.C.s — which includes the hearing aids, clinical and product service, and warranty – average about U.S.$2,400 per standard hearing aid or U.S.$4,800 for two hearing aids, making hearing aids the third largest purchase for many after a house and a car. This bundled pricing strategy reduces the transparency of services provided and may have stipulations that limit the user's choice. For instance, some hearing aids can only be serviced by the original dispenser, which limits the ability of the user to change service providers if they are dissatisfied.

TABLE 5: VALUE CHAIN IN THE PRIVATE SECTOR

	COMPONENT SUPPLIERS	HEARING AID MANUFACTURERS	RETAILERS/AUDIOLOGISTS	COST TO PAYERS
Percentage of value chain
U.S.$ Value	U.S.$20-30	+ U.S.$300-600	+ U.S.$1,900-2,100	Total = ~U.S.$2,400
Role in Value Chain	Supply of hearing aid components (e.g. microphones)	R&D Manufacturing Marketing & Sales Distribution Warranty	Retail (usually standalone) Fitting Services/Maintenance	N.A.

4.2. The Big 5 are focused on premium products to generate market value and have limited commercial interest in L.M.I.C.s.

The Big 5 have a limited presence in non-Western markets. For example, for William Demant, the Asia-Pacific accounts for 21% of unit sales, mostly from Japan and China. South America and Africa account for only 7% and 2% of unit sales, respectively. 49 The Big 5 see limited commercial interest in L.M.I.C.s due to the following factors:

• LOW AWARENESS AND STIGMA. Awareness of hearing loss is very low in L.M.I.C.s. Even when people are aware, stigma associated with the use of hearing aids exists.
• LIMITED ACCESS TO HEARING CARE PROFESSIONALS. The low availability of audiologists is often cited as a barrier to scale by many major hearing aid suppliers.
• REGULATORY CHALLENGES. In some L.M.I.C. markets, registration of new hearing aid products can be time-consuming, particularly when compared to H.I.C. markets. In addition, in many L.M.I.C.s low-cost products that are often unregulated exist. Big 5 products cannot compete on price with these low-cost hearing aids and personal sound amplification devices.
• LOW PURCHASING BY USERS OR GOVERNMENTS. L.M.I.C. governments are typically not prioritising hearing aids within a constrained resource envelope. Where governments do procure hearing aids or cover them through an insurance scheme, suppliers have faced long sales cycles, late payments, and government reimbursement rates that are too low to cover costs, which limits their desire to interact with government as a customer (refer to Case Study 4).

While prices for hearing aids are often prohibitive to L.M.I.C. buyers, manufacturers are reluctant to reduce rates due to concerns about price erosion. The above-mentioned challenges, in combination with a H.I.C. market that is not yet saturated (e.g. H.I.C. market has ~20% market penetration), lead to companies focusing on high-value markets. New generation products are launched every 3 years and are the main driver of market value growth. In the absence of public spending and given the constrained size of the private market in most contexts, N.G.O.s and C.S.R. initiatives are sometimes the only hearing aid provision occurring within a country.

4.3. To meet the needs of lower-income market segments, approaches exist in the private sector that can deliver quality hearing aids in more affordable ways to the end-user.

Commercially viable enterprises exist that are seeking to work with or around the Big 5 in order to provide a lower cost but high-quality product and service, both in H.I.C.s and L.M.I.C.s:

• DIRECT-TO-CONSUMER. IntriCon (U.S.), the largest manufacturer outside of the Big 5, is developing a “direct-to-consumer” distribution channel as they believe that the conventional retail model is inefficient and costly. This model sells a hearing aid to the user similar to those from Big 5 at a price between U.S.$350-500.

• WHITE LABEL BUNDLED PRODUCT AND SERVICE.Costco (U.S.) is the second-largest provider of hearing aids in the U.S. after the U.S. Veteran Affairs. The retailer's bundled price is U.S.$1,499 for a pair of hearing aids, 51 offering significant costs savings to users compared to traditional retail channels. It does so by:

  • LEVERAGING PREVIOUS GENERATION TECHNOLOGY AND WHITE-LABEL PRODUCT. Costco procures its hearing aid from leading hearing aid manufacturers, selling some with name brands and some under the ‘Kirkland’ private label. They often buy products that are one generation behind, thereby accessing discounted prices.
  • VOLUME PURCHASING. Costco has an 11% market share, which enables them to bulk purchase from manufacturers and transfer these savings to its customers. They retender on an 18-month cycle.
  • LOWER OVERHEADS. Costco utilises its current brick and mortar infrastructure to reduce overhead costs by building a hearing aid centre within its existing shops.
  • LOWER-SKILLED PERSONNEL. Costco employs hearing aid specialists who require minimal training. Individuals with a high-school diploma are required to pass a licensing exam, administered by Costco, and then be engaged in a brief apprenticeship. This allows them to pay lower wages compared to an audiologist. The compensation model does not rely on sales commissions, further reducing cost to users.
• SELLING ENTRY-LEVEL PRODUCTS VIA LOCAL PHARMACY CHAINS.earAccess, a Canadian social enterprise, also utilises white labelling. In 2018, the company launched two entry-level products (ACCESS 1 B.T.E.: U.S.$250-300; ACCESS 2 B.T.E. Power: U.S.$750-1,300) in collaboration with a local pharmacy chain in the Philippines 52 that has placed audiologists in select stores for the provision of hearing aids. 53 , 54 They are targeting a 70% reduction in price for consumers compared to currently available hearing aids through volume-based purchasing from a contract manufacturer, reduced product margins, and leveraging this alternate distribution channel. 55 18
• SUBSCRIPTION-BASED MODEL. One of the key challenges with increasing access to low-income customers is the high upfront cost of device acquisition in the retail sector. New concepts are emerging whereby a company partners with mobile money operators, local N.G.O.s, and basic health service providers to screen patients and then provide hearing aids on the spot. The hearing aids are financed via a subscription model in which the user pays an affordable rate per week for a fully serviced hearing aid plan, including earmoulds and batteries, over a period of 36 months, via mobile money transfers.

The above suggests that innovation in sales models may be able to expand the reach of the private sector to new consumers. Direct-to-consumer approaches may be challenging due to the fact that many potential users have low technological savvy to engage with the self-fitting technologies, or are limited in ability to access online ordering. However, principles of using white labelling and volume purchasing to provide an affordable option to consumers, or lowering delivery costs by leveraging existing pharmacy chains both show promise. Subscription-based models, if able to demonstrate profitability and sustainability, could also change the way that end-users are able to sustainably afford hearing aids.

4.4. In the absence of a global standard, quality products struggle to compete in unregulated markets as many low-cost suppliers have emerged that have products of variable or unknown quality.

In order to respond to the need for hearing aids at lower price points in L.M.I.C.s, multiple smaller manufacturers, primarily Chinese, offer products at lower prices but of unknown quality. These include suppliers who are either manufacturing in L.M.I.C.s or primarily supplying to L.M.I.C.s. These companies have not been able to establish any reputation and due to the lack of global quality certifying mechanisms, it is difficult to differentiate between high and low quality in this category.

FIGURE 4: HEARING AID SOLD THROUGH SMALL ELECTRONIC STORES

Anecdotally, quality concerns include poor sound amplification, over-amplification, lack of directional microphones, and poor durability. Products, as seen in Figure 5, are commonly sold through an unregulated market at retail points, such as small electronics shops, at price points as low as U.S.$4 and often without appropriate tests or provision.

4.5. National health insurance systems in H.I.C.s have been able to increase adoption rates, sustainably deliver services and reduce prices obtained on Big 5 models through volume-based negotiation.

By having a centralised payer or provider, public systems are able to conduct centralised procurement and leverage volumes to achieve reduced prices, thereby increasing adoption and accessibility of hearing aids. For example, while the penetration of hearing aids in many H.I.C. is on average only 20%, in countries such as Norway and the U.K., the strength of a publicly supported provision system has contributed to ~45% market coverage. 56 , 57 In these countries, governments play a critical role in providing the funding for products and provision, and negotiating terms with suppliers, while service provision may be delivered by either the public sector or contracted out to the private sector.

For example, N.H.S. England is a public procurer that conducts volume-based negotiation to drive down prices (refer to Case Study 4). U.K. tender information is made available on the E.U. website and is often consulted by E.U. countries that are procuring hearing aids. However, under U.K. regulations, other countries 19 are not able to procure from the procurement framework. 58 Over time, the prices have proved sustainable, and as volumes have increased, prices have further decreased. 59 The Clinical Commissioning Group for each local area within the N.H.S. sets the tariff for reimbursement of providers (both public and private) contracted to provide hearing services. The recommended tariff for 2016/2017 for hearing assessment, fitting of two hearing aids device, cost of two devices, and three years of follow up was around G.B.P.£370 but can vary based on a number of adjustment factors. 60

CASE STUDY 5: N.H.S. ENGLAND HEARING AID PROCUREMENT 61 , 62

N.H.S. England provides hearing aids free of charge to end-users as part of the U.K.'s system of universal health coverage. N.H.S. England purchases and dispenses 1.2 million hearing aids every year through more than 300 hearing service clinics. 63 Over time, the N.H.S. has developed a system that allows them to procure high-quality hearing aids from Big 5 manufacturers at an affordable rate, averaging G.B.P.£56 (U.S.$68). The approach is led by the N.H.S. Supply Chain office and is characterised by the following:

Image Description

A line chart that compares the number of hearing aid units procured over 8 fiscal years from 2007-2015 with the average pricing for these units over this time period.

• Consultations with potential suppliers in advance of the release of the tender specification documents;
• Clear specifications around a limited range of products that cover the entire spectrum of needs and that focus on items with basic features;
• Consolidated volumes across N.H.S. departments that procure hearing aids, allowing for volume-based negotiations with multiple suppliers, including minimum order commitments in some cases;
• Extensive quality testing

4.6. While there is potential to increase adoption of affordable and quality hearing aids, there is currently a considerable lack of effective public procurement in L.M.I.C.s.

Unlike the examples of H.I.C.s provided above, in L.M.I.C.s current investment in procurement and provision of hearing aids by the public sector is low or non-existent. Governments are not prioritising procurement of hearing aids within limited budget envelopes. Where a limited number of countries do procure hearing aids for public provision, procurement volumes tend to be far below the immediate need, as characterised by growing waiting lists and the projected need that could be addressed with hearing aids.

Additionally, tendering practices related to hearing aids demonstrate significant weaknesses, further limiting access to optimal products:

• POOR SPECIFICATIONS.In some cases, tender documents do not provide sufficient specifications on the types of product required and do not align with W.H.O. P.P.P. as governments and decision-makers are unaware of the P.P.P. or have not fully adopted it. In other cases, the specifications 20 promote the proliferation of products. This results in a fragmented market with multiple products that are similar in functionality, and lack of consensus on which products would be best included in a public model of provision. Experts suggest that meeting a range of user needs only requires a few, adjustable hearing aid models.
• PRICE OVER QUALITY. In the absence of strong specifications and clear quality standards, national procurements tend to go to the lowest bidder, regardless of whether it is an appropriate or quality product. At these low prices, Big 5 manufacturers do not see the value of competing. There are also examples in L.M.I.C.s where the government tenders local manufacturers, regardless of cost or quality considerations.
• IMPORT DUTIES AND TAXES.In many countries, hearing aids are not exempt from import duties and taxes, such as sales or V.A.T., which can have a significant impact on the price of the product to the consumer and the ability for governments to procure. In one middle income country for example, import duties on hearing aids are as high as 15% and V.A.T. is 10%. This essentially increases the price of the product by 26.5% to the buyer. 64

4.7. N.G.O.s have found ways to access quality hearing aids at an affordable rate and provide cost-effective services, pointing to potential approaches that L.M.I.C. governments could use to access affordable, quality products.

N.G.O.s have been able to access quality products at lower cost for humanitarian use (refer to Case Study 6). N.G.O.s, benefiting from these pricing agreements, believe that these humanitarian prices still incorporate a small profit margin for the manufacturer. Other models for procurement that N.G.O.s use, but that are less likely to be replicable at scale, include refurbishing donated product and accepting donated product from hearing aid companies through C.S.R.. 65

To combat limited awareness and stigma associated with hearing loss, N.G.O.s have adopted service delivery models in L.M.I.C.s that bring services closer to people. These models often involve using lower cadres of workers (refer to Case Study 7). Examples include door-to-door screening for hearing loss and provision of care; campaigns and outreach programs at schools and in communities; partnerships with government health facilities; and standalone hearing clinics, sometimes in partnership with universities or private health facilities.

These models also help overcome the need for the user to visit the audiology clinic multiple times before the hearing aids are working optimally and help reduce high drop-out or conversion rates. A study conducted in Malawi outlined that referral uptake for ear and hearing services was only 3% due to a variety of factors including location of the hospital, other indirect costs of seeking care, procedural problems within the outreach programme, awareness and understanding of hearing loss, and lack of visibility and availability of services. 67

4.8. There is limited scope to optimise or relocate manufacturing to generate additional cost reductions in the price of hearing aids.

Bulk manufacturing of hearing aids in centralised production factories is the standard manufacturing model employed by global suppliers. Production follows standard methods for small electronics manufacturing. Components such as microphones and transducers are sourced, while the hearing aid manufacturer is adding a plastic case and the proprietary software and assembles the final product. The production facilities, which are fairly automated, 69 are set up across the globe — most commonly in Asia — to optimise sourcing of components, assembly and distribution of hearing aids in L.M.I.C.s and H.I.C.s.

Establishing a localised approach to production and assembly can in some cases lead to lower cost, high-quality assistive products for users. Potential advantages of localised production include potential avoidance of import taxes, reducing shipping costs, producing a product that is optimal for the local environment, and creating employment locally. However, in the case of hearing aids, it is unlikely that localised manufacturing would be able to lower costs in this way, because:

• LIMITED SCOPE TO REDUCE THE COST OF COMPONENTS. Microphones and transducers are the most expensive components for hearing aids and there is limited buying power for hearing aid manufacturers to negotiate prices. The global supply of microphones and transducers is controlled by two suppliers, Knowles and Sonion. These companies provide technologies for a range of different applications and hearing aid manufacturers are relatively smaller clients of these companies compared to other large technology companies.
• ASSEMBLY REQUIRES SKILLED LABOUR. While most of the hearing aid process is automated, the final production step of encasing the technology within a plastic frame is manual and requires significant training in electronics.
• HIGH UPFRONT COSTS. Since hearing aids are small and sensitive hearing technology, production requires relatively high up-front investments in specialised equipment and production facilities to assemble the miniature electronics at high quality.

Local assembly of hearing aids has taken place in some countries such as Brazil, India, Botswana, Vietnam and the Philippines to attempt to reduce the burden of import duties on hearing aids. In such a model, manufacturers might be incentivised, if volumes are sufficient, to supply semi-knocked-down kits to local businesses that then assemble hearing aids. 70 Semi-knocked down kits usually require only soldering the transducer(s) onto the printed circuit board and closing the unit with small screws.

The assembly model has had limited success because cost reductions are small, manufacturers are wary of quality control of the final product, and manufacturers may have to disassemble existing stock of hearing aids to provide the broken-down kits.

Several suppliers of lower cost hearing aids—often based in Asia—have emerged and experts suggest that some companies are offering products of sufficient quality for global markets. While limited opportunities may exist to negotiate better prices of components, streamlining the production of a range of basic generation models may result in favourable manufacturing economics such as: fewer change-overs/down-time of manufacturing lines; more efficient planning; optimised logistics and a higher degree of standardisation in sourcing and production.

4.9. The advent of new technologies for hearing loss screening and diagnosis and hearing aid fitting may address service delivery capacity constraints and create opportunities to reach more people.

Since 2004, when W.H.O. guidelines on hearing aids provision were last updated, there has been considerable innovation in the field of otoscopy and audiometry, decreasing the skill level required for these services and creating the potential to increase access.

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4.9.2. Audiometers

Pure-tone audiometry is the gold standard to identify people with hearing loss, but most audiometers that are currently in use are complex, require extensive training and experience that only audiologists have, and require a sound-proofed environment. Mobile audiometers such as those by SHOEBOX, HearX and KUDUWave address some of these critical challenges (Table 6). HearX and SHOEBOX are tablet-based audiometers, with specialised software and headphones. KUDUWave is a headset that is able to perform automated audiometry. These devices are clinically validated and have also undergone some field-testing.

TABLE 6: MOBILE AUDIOMETERS

PRODUCT NAME	SHOEBOX AUDIOMETRY 73	KUDUWave	HearTest
Manufacturer	SHOEBOX Ltd. (Canada)	eMoyo (South Africa)	HearX Group (South Africa)
Description	iPad-enabled software screening and diagnostic software	Portable and boothless screening and diagnostic audiometer	Portable, Android mobile-enabled screening and diagnostic software
Audiogram Output	Yes	Yes	Yes
Included in upfront bundled costs	iPad with Software, calibrated Radioear headphones, cloud-based data management, warranty, annual calibration	Sound-booth equivalent noise blocking headset audiometer, consumable pieces, software, internal microphones, ear tips, 3-year warranty, digital calibration	Samsung phone with software, calibrated audiometric headphones, cloud-based data management, subscription-based software, 2-year warranty, annual calibration
Upgrade options	Bone oscillation, customized managed service, custom integration	Bone oscillation (Plus + Pro); Built-in tympanometer (Pro T.M.P.)	Extended high-frequency audiometry, Advanced attenuation option, video-otoscope (hearScope) integration
Personnel Requirements	Standard – Minimal Training Pro – Audiologists / E.N.T. surgeon only	Minimal Training Required	Minimal Training Required
Power	iPad charger	Requires connection to a PC/Laptop	Battery or phone charge, offline & online
Tele-audiology enabled	Yes	Yes	No

Product photos used with company permission.

Some of the advantages of these devices include:

• LOWER SKILL REQUIREMENTS.Automated audiometry capabilities allow lower-skilled workers to provide diagnostic services in uncomplicated cases. The training to effectively operate these devices can be between 1-3 days for nurses, primary healthcare workers or community health workers. 24
• POTENTIAL FOR SELF-CALIBRATION. Although annual calibration is not clinically required with the current generation of equipment, this has been set as an industry requirement and is often mandated by the government. These calibrations are usually performed by local distributors, but if none is available locally, audiologists are required to incur shipping costs to send the product to their closest distributor for re-calibration. Calibration can, therefore, be a costly service and disruptive to service delivery. However, SHOEBOX re-calibration services are included in the annual subscription fee. HearX is currently setting up remote calibration facilities for its devices and also offer swap-out options to ensure minimal downtime for customers. KUDUwave includes digital calibration verification where the device completes its own calibration electro-acoustically and the manufacturer eMoyo only requires regular calibration every three years.
• LOWER INFRASTRUCTURE REQUIREMENTS. Current screening and diagnostic protocols also require the use of a sound booth among other related infrastructure requirements. Not only are these sound booths expensive and difficult to build, but they are not portable. This limits the ability to conduct outreach services. Mobile audiometers, because they use noise-cancelling headphones and algorithms that address noise interference in the environment, can be used in a quiet setting.
• LOWER COSTS. Lower device costs, lower skill and training requirements, and reduced time per screening support overall reduced costs per screening.

Many of these companies are already working with governments. For example, KUDUWave works with the government of South Africa for their school screening program and has been used by healthcare workers for hearing screening within other public health programs. Uptake of these devices is limited by lack of field evidence to support use at scale and across a variety of different contexts.

4.10. Innovative models of hearing aids have the potential to facilitate greater access to hearing aids in L.M.I.C.s.

Although most of the innovation in hearing aids at present is driven by Big 5 investment in high-end product, some of the latest innovations in hearing aid technologies may present opportunities to improve the availability of hearing aids in L.M.I.C.s.

Strategic Objective 1: Strengthen global policy guidance around service delivery, product selection and product quality

Strategic Objective 2: Support L.M.I.C. governments to strengthen hearing aid provision including demand generation and investing in service delivery capacity, government purchasing and procurement support

Strategic Objective 3: Engage the private sector to expand delivery of affordable, quality hearing aids and related services

Strategic Objective 4: Work with suppliers to enter L.M.I.C. markets with affordable, quality hearing aids

Strategic Objective 5: Spur innovation to support simplified provision models and introduction of optimal products