Following the signing of the Over-the-Counter (OTC) Hearing Aid Act of 2017, the FDA was on track to issue regulations by the law’s deadline of August 2020. That deadline has come and gone without new rules in place.
During this period, bad actors have stepped in to fill this vacuum and begun to advertise OTC hearing aids on television and on the internet, even though there are no products that can claim to be OTC hearing aids, according to the FDA Hearing Aids | FDA. Nonetheless, these bad actors claim to be “FDA cleared or FDA Registered” which is a term that may be misconstrued by the general public as “FDA approved.” FDA registration is an administrative designation and is required of any owner or operator of a facility involved in the production or distribution of medical devices intended for use in the United States. The FDA website itself states that “registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
HLAA is concerned that consumers might purchase these personal sound amplification products (PSAP) instead of traditional hearing aids, assuming these devices are legitimate OTC hearing aids. PSAPs are not interchangeable with hearing aids, are not intended to compensate for or treat hearing loss, and do not provide the sound filtering that an FDA-approved hearing aid does.
HLAA sent a letter to Commissioner Hahn of the FDA urging swift action to put regulations in place that will set in motion the development and sales of actual OTC hearing devices. With the rules in place, consumers will have the opportunity to access devices that will benefit them and be affordable as well.