Many of the established players in the hearing industry have long been upset about lack of clarity in the lines drawn between hearing aids, which are regulated medical devices, and personal sound amplification products (PSAPs), which are unregulated. Now three major hearing health organizations are tackling the issue head on by calling on the U.S. Food and Drug Administration to have four PSAP providers “cease and desist” from marketing their products as hearing aids intended to rectify hearing loss.
The joint letter from the Academy of Doctors of Audiology, American Speech-Language-Hearing Association, and International Hearing Society said companies selling the Neutronic Ear, RCA Symphonix Sound Amplifier, Lee Majors Bionic Hearing Aid, and TV Ears Sports Amplifier may be violating FDA and state regulations requiring marketers of hearing aids to request a full medical evaluation from customers–including a recent hearing test administered by a licensed hearing aid fitter or audiologist–or have them sign an explicit waiver.
The FDA guidance statement drawing the distinction between unregulated personal sound amplifiers and regulated hearing aids is clear enough:
PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act.
However, translating that guidance into marketplace behavior has caused some confusion, according to the hearing organizations: “While we feel there is a place for PSAPs in the marketplace, unfortunately, it appears there may be continued confusion, or perhaps blatant disregard, by some Vendors with regard to the guidance and regulations put forth by the FDA to protect consumers….We have observed many companies that we believe may be marketing hearing aids directly to consumers as personal sound amplifiers, either themselves or through outside Vendors.”
Stating that PSAP vendors are marketing their products as solutions for hearing loss, in direct violation of the FDA guidelines, the letter says “We urge the FDA to clarify and strengthen its regulations over companies that illegally market hearing aids as PSAPs.” Then the letter provides details on each of the named vendor’s products to support its claims that “vendors’ products are hearing aids, not PSAPs.”
The contention between traditional hearing aid manufacturers and the burgeoning group of new companies that see hearing assistance as a major new market opportunity has been growing. After CNBC’s recent report on hearing aids as the next booming market for startup technology companies, the International Hearing Society (IHS) sent an open letter to CNBC criticizing the network for positioning hearing aids as “consumer electronics devices” rather than medical devices, “undermining state and federal laws that identify hearing aids as medical devices.”
The IHS letter goes on to caution that an inexpensive hearing aid without a proper fitting from a trained hearing health professional can do more harm than good:
Imagine if someone in need of a prosthetic arm or leg were delivered a one-size-fitsall device in the mail – without being customized for their limb and with no therapy or rehabilitative support. Their chances of long-term success would be quite limited. Hearing aids are much the same – personal fit and adjustments, as well as counseling and support significantly increase one’s success.
The recent push-back to the wave of new unregulated personal amplifiers on the market is only the start of what we can expect will be a long process as consumers, manufacturers, the hearing health industry and regulators evaluate and start using new technologies that will continue to make their way into the marketplace. Stay tuned.