HIAThe Hearing Industries Association (HIA) submitted a comprehensive Addendum on June 30, 2016 to the Food and Drug Administration (FDA) in response to the questions posed by the FDA at its April 21, 2016 Workshop regarding hearing healthcare and hearing devices in the US.

In its Addendum, the HIA reiterated its position on several issues related to hearing healthcare in the US, stressing both the critical need to appropriately treat hearing loss, and the crucial role of hearing professionals in providing treatment for people with hearing loss that lead to successful outcomes. Citing the testimony of numerous witnesses, HIA emphasized the importance of FDA regulation to ensure hearing aid effectiveness and safety, and to avoid a marketing “race to the bottom” that would accompany deregulation of the hearing aid market.

FDAIn its Addendum comments, HIA highlighted significant differences between reports and recommendations from a special panel of the National Academies of Sciences (formerly known as the Institute of Medicine, or IoM) and the President’s Council of Advisors of Science and Technology (PCAST) in regard to the FDA’s regulatory role. The National Academies described personal sound amplification products (PSAPs) as consumer electronic products that are not intended to address hearing loss. This is consistent with the position the HIA has taken, as outlined in its May 2016 comments to the FDA urging the Agency to finalize its 2013 Draft Guidance, as well as its own position on the matter. The National Academies panel also acknowledged that the regulatory distinction between PSAPs and hearing aids “might not be readily apparent to users, and it might not be fully respected by PSAP sellers who explicitly or implicitly offer their products to compensate for hearing loss.”

In its report, the PCAST recommended that the FDA abandon nearly all regulations related to the manufacture and sale of OTC hearing aids. The National Academies panel, on the other hand, noted that these regulations are important in ensuring safety and effectiveness for users. Although the National Academies panel recommended the creation of a new class of OTC hearing devices, it also noted the critical importance of professional services to achieving optimal outcomes.  Numerous witnesses at the FDA Workshop in April also questioned whether consumers can appropriately self-diagnose, self-treat, and self-manage their hearing loss.

Although it articulated its support of greater access in the Addendum it submitted to the FDA, HIA also demonstrated why neither PSAPs nor OTC hearing aids were the right solution for consumers with hearing loss.

According to the HIA, the FDA will be posting all comments related to the April 21 Workshop.

Source: Andy Bopp, HIA