Washington, D.C. – Over 4 million hearing aids are purchased in the United States each year, and a bicameral, bipartisan group of lawmakers are working on consumer protections for those who rely upon these devices.

Advancements in technology allow digital hearing aids to be programmed to optimize the acoustical fit for each individual patient. However, some manufacturers use proprietary or “locked” software that can prevent consumers from having theirhearing aids repaired unless they return to the original manufacturer or network-affiliated clinic. If the consumer has moved, is traveling when their device breaks, or the company has gone out of business, they may be left without a fully functioning hearing aid or have to purchase a new one. Because of a lack of disclosure requirements, many consumers are unaware of these possible restrictions when purchasing these costly devices.

U.S. Rep. Kevin Mullin (CA-15) and Senator Elizabeth Warren (MA) led a bipartisan letter to the U.S. Food and Drug Administration from 15 Members of Congress encouraging them to strengthen protections for consumers with hearing loss by considering proactive ways to inform them if they are purchasing locked hearing aids. Rep. Mullin wears hearing aids in both ears and helped enact a similar law in California during his time as a member of the California State Assembly.

“I know firsthand how reliant people with hearing loss are on these devices and it’s wonderful that today’s advanced technology allows hearing aids to be programmed to fit the specific needs of each consumer,” Mullin stated. “However, so many people already struggle to afford these life-changing devices, so it’s important that they are empowered to make informed decisions about how to minimize future costs.”  

“I pushed hard for over-the-counter hearing aids to increase competition and lower costs for seniors,” said Senator Warren. “But some hearing aid manufacturers restrict where and how their products can be repaired, making it unnecessarily difficult and expensive for consumers who rely on hearing aids – whether prescription or over-the-counter devices – to fix them if they break. I’m calling on FDA to support right-to-repair and ensure consumers can get the hearing aid that works best for them.”

The lawmakers are asking the FDA to inform consumers by, at a minimum, requiring a disclaimer on the label of the hearing aid about whether it contains proprietary software and must be repaired or adjusted by the original manufacturer or network-affiliated clinic . This policy would not prohibit the use of proprietary hearing aid software but would help ensure that the consumer is notified in writing of the existing parameters.

Recent studies suggest that hearing aids can help reduce mortality rates of those with hearing loss and are critical to prevent social isolation, depression and cognitive decline. This consumer protection effort has received widespread support with the endorsements from the American Academy of Audiology, Hearing Loss Association of America, National Disability Rights Network, Disability Rights Education and Defense Fund, Disability Rights California, and Northern California Services for the Deaf and Hard of Hearing.  

Four Senators and 11 Representatives signed onto the letter, which can be read here:

Document

Urging Protections for Individuals with Hearing Loss.pdf (476.09 KB)

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