The Hearing Industries Association (HIA)—the national trade association for manufacturers of hearing aids—believes that if the U.S. Food and Drug Administration (FDA) creates an Over-the-Counter (OTC) hearing aid category as required by legislation now under consideration in Congress (S.670/H.R.1652), such medical devices should meet the same FDA standards as existing hearing aids and should be offered only to people with mild hearing loss, HIA announced.
HIA continues to support efforts to increase the accessibility and affordability of hearing aids, including many proposals offered in 2016 by the National Academies of Sciences, Engineering, and Medicine (NAS) Committee on Accessible and Affordable Hearing Health Care, and is eager to work with the committee at the upcoming June 9, 2017 meeting.
HIA Chairman, Brandon Sawalich, noted: “If the quality of a new category of OTC hearing devices is safeguarded, and the products are marketed only to people with mild hearing loss, consumers who try the new OTC devices may have a positive experience and potentially seek further treatment if their hearing loss progresses.”
He added: “But if the quality of OTC hearing products is not ensured, consumers may abandon their effort to address hearing loss altogether, putting them at increased risk of long-term complications of untreated hearing loss.”
It’s been said that the risks of failure and further delay in obtaining an accurate diagnosis of underlying cause and effective treatment are significantly greater for individuals with moderate hearing loss.
HIA believes it’s important to acknowledge that if FDA creates an OTC hearing aid category, consumers of these products will not be required to obtain professional guidance to determine the cause or degree of hearing loss, or how to effectively use and adjust the devices.
HIA therefore urges FDA to require that all OTC hearing aids meet the same safety and efficacy standards that the agency requires of air-conduction hearing aids fitted by hearing health professionals to increase the likelihood that OTC hearing aids would be safe and effective for people with mild hearing loss.
Of crucial importance, HIA urges FDA to review and finalize its 2013 draft Personal Sound Amplification Products (PSAP) Guidance document shortly to make clear that unregulated PSAPs cannot be marketed to address hearing loss. People with mild hearing loss who seek a self-directed solution would instead have the option to purchase an OTC hearing device, once cleared by FDA, rather than an unregulated PSAP or other consumer product.