By David H. Kirkwood
WASHINGTON, DC–Three national associations of hearing care professionals have added their voices to that of the Hearing Industries Association (HIA) in calling on the Food and Drug Administration (FDA) to take action to curb the sale of hearing aids under the guise of personal sound amplification products (PSAPs).
Although the manufacture, marketing, and sale of hearing aids come under FDA regulation, the agency does not regulate PSAPs, which, it says, have a different, non-medical purpose. Specifically, the agency explained in a February 2009 guidance document:
“A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing-impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities.”
However, manufacturers and dispensers of hearing aids have complained, despite its own guidance document, the FDA has turned a deaf ear to the aggressive marketing of a slew of products clearly intended for use by people with hearing loss. Thus far, the agency has failed to respond to their complaints.
ASHA, IHS, AND FDA SEND JOINT LETTER
Most recently, leaders of the American Speech-Language-Hearing Association (ASHA), the International Hearing Society (IHS), and the Academy of Doctors of Audiology (ADA) signed a joint letter to Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health.
The letter, submitted August 31 on behalf of the audiologists and hearing aid specialists represented by the three bodies, stated, “Collectively, we are seeking the FDA’s action to address concerns with hearing aids being sold as PSAPs.”
RISK TO CONSUMERS SEEN
The signatories (Stephanie Czuhajewski, executive director of ADA; Arlene Pietranton, CEO of ASHA; and Kathleen Mennillo, executive director of IHS) made three key points in their letter.
• “Vendors may be selling hearing aids advertised as being ‘designed for mild to moderate hearing loss’ or that provide significant dB gain, appropriate for someone with mild to moderate hearing loss, but are advertising the devices as PSAPs. We urge the FDA to clarify and strengthen its regulations over companies that illegally market hearing ads as PSAPs.”
• “Some vendors appear to be targeting consumers with possible hearing loss with a ‘direct-to-consumer’ medical device in contravention of the FDA’s disclosure regulations and guidance, which were adopted to protect consumer safety.”
• “Some vendors may be engaging in marketing activities that may put consumers at risk of purchasing unnecessary hearing aids, or devices that may be unsuitable for the consumers’ needs or provide excessive gain leading to hearing damage and/or place consumers at risk of delaying or preventing the diagnosis and treatment of serious medical conditions.”
In their letter, the three hearing health organizations urge the FDA to investigate certain vendors “to determine whether they are violating the FDA regulations and, if appropriate, send warning letters instructing violating parties to cease and desist marketing and/or distributing these products for not complying with FDA regulations.”
The letter went on to list several possible violators of FDA regulations: Neutronic Ear, RCA Symphonix Personal Sound Amplifier, Lee Majors Bionic Hearing Aid, TV Ears Sports Amplifier.
The ASHA-IHS-ADA letter also asked that the agency make its non-binding guidelines on PSAPs mandatory.
HIA SENT A SIMILAR MESSAGE
As was reported on this blog earlier, Jeffrey Gibbs, counsel to the Hearing Industries Association, made many of the same points in a letter sent to Steven Silverman at the FDA on April 19, 2012.
Gibbs wrote, “We request that you take enforcement action against the companies making hearing aid claims for their PSAPs.” He added, “Given the widespread nature of these violations, and the abuse of the [FDA] guidance document ‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’ we request that you revise the PSAP Guidance to both tighten and reinforce the limits of the claims that may be made by PSAP manufacturers.”
He added, “The failure to act will result in the erosion of the consumer protections that the FDA has established for hearing-impaired individuals, simply by allowing companies to market hearing aids as ‘PSAPs.’”
So far, the FDA has failed to respond either to this letter or to a follow-up message that the HIA sent last month after The Wall Street Journal reported, “A wave of new devices that are smaller, hipper and sold over-the-counter are trying to win over more consumers—and appeal to the growing number of younger people with hearing damage from loud music.”
Attempts by Hearing News Watch to reach FDA officials about the issue have not yet been successful.