A company manufactures a device it calls a hearing aid, markets it to people with mild to moderate hearing loss, and claims the device takes advantage of the most modern hearing aid technology—but is not required to follow federal regulations on the sale and marketing of hearing aids.
What's going on?
That's what ASHA and two other organizations want to know, and they filed a joint letter Aug. 31 asking the U.S. Food and Drug Administration (FDA) to investigate the sale of two types of hearing devices: hearing aids and personal sound amplification products (PSAPs).
ASHA's concerns—shared by the Academy of Doctors of Audiology and International Hearing Society—are based on hearing aids being sold as PSAPs, because the two devices fall under different sets of regulations.
A hearing aid—defined by the FDA as a wearable sound-amplifying device intended to compensate for impaired hearing—are medical devices under the Food, Drug, and Cosmetic Act and may not be distributed or dispensed without an examination by a medical doctor, unless the consumer waives the requirement.
A PSAP—defined by the FDA as a wearable electronic product not intended to compensate for impaired hearing—is designed to be used by consumers with normal hearing to amplify sounds related to various recreational activities (for example, hunting, bird watching, listening to a lecture). A PSAP is not subject to FDA hearing aid regulations.
The letter outlines several issues:
- Several retailers are selling hearing aids without requiring customers to waive their responsibility to see a physician or hearing health professional.
- Many companies may be marketing hearing aids directly to consumers—either on their own or through outside retailers—as personal sound amplifiers, so as to avoid FDA regulations on hearing aids.
- In at least one case, identical devices are marketed differently—in some instances as hearing aids and in others as PSAPs—based on the seller.
The letter names several products that may be violating FDA disclosure regulations, and urges the FDA to investigate them and, if appropriate, instruct the violators to cease and desist marketing and/or distributing these products.
The letter also identifies several products marketed as PSAPs (rather than hearing aids) that advertise as "designed for mild to moderate hearing loss" or that provide significant dB gain. It calls on the FDA to investigate these unregulated products and to clarify and strengthen regulations prohibiting the sale of hearing aids as PSAPs.
Retailers may be putting consumers are at risk, the letter states, for purchasing unnecessary hearing aids or devices unsuitable for their needs. In addition, an inappropriate device could lead to hearing damage or delay or prevent the diagnosis and treatment of serious medical conditions.
The three organizations expressed their willingness to work with the FDA, suggesting that the FDA clarify and strengthen—or replace—the PSAP regulations to address the online and retail sale of the devices.