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.
In 2017, the U.S. Government passed the O.T.C. Hearing Aid Act that required the F.D.A. to create regulations on a new class of O.T.C. devices for users with mild and moderate hearing loss with the goal of improving accessibility. As the regulations are expected to be released and implemented in 2020, it is difficult to ascertain the exact products that will be covered and the impact that this regulation will have on the market.
Discussions with experts78 suggest that O.T.C. regulations could have a variety of benefits:79
Potential challenges associated with the advent of O.T.C. hearing aids could include users self-classifying as mild to moderate loss and eschewing professional diagnosis and service. Additionally, these devices may still be out of reach for many based on pricing levels.
In 2018, the F.D.A. granted an application for the first Self-fitting Hearing Aid (S.F.H.A.) by Bose, which is yet to come to market.80 According to the F.D.A., an S.F.H.A. is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software that allows users to program their hearing aids through a smartphone.81 Approval was granted because Bose submitted studies demonstrating that their S.F.H.A.s can provide similar sound amplification performance and experience to users as traditional hearing aids provided by a professional.82 These devices are classified as a Class II medical device by F.D.A. and are targeted towards users over the age of 18 with mild to moderate hearing impairment.83 These devices are currently considered to be separate from the O.T.C. hearing aid devices classified above as regulations on O.T.C. hearing aids are not yet established. Other S.F.H.A.s available in the market include devices that have been designated as hearing aids or personal sound amplification products dependent on country regulations, from Sound World Solutions and NuHeara. While S.F.H.A.s have not been extensively used in L.M.I.C.s, demonstration projects utilised Sound World Solutions' devices have shown that there is potential to use S.F.H.A.s to simplify provision. Low-skilled healthcare personnel can be more easily trained to fit self-fitting hearing aids as they allow for the automation of more complex tasks in the assessment and fitting process, reducing training requirements and expertise level.
Pre-programmable hearing aids are based on the premise that most hearing aid users within a population can be served using a few, select hearing aid models with pre-set amplification protocols. Rather than generating a custom fit for each user, the pre-set protocols would mimic common “shapes” of hearing loss audiograms, and then volume could be adjusted up or down by the user or a low-skilled provider. The supplier could preload a hearing aid with the present shapes and a hearing professional could select a pre-set shape in response to the audiogram. Experts suggest that there can be a strong benefit to these hearing aids in L.M.I.C.s. While there has been limited research on which present audiological profiles would best serve specific populations, there has been growing interest within the hearing health community to investigate the technical and operational potential for these types of hearing aids. Research would be required on the shape of audiological profiles in the population, as well as operational experience with using different models of pre-programmable hearing aids to determine if there is a significant benefit.