Hearing Aids Over-the-Counter? No Way, Some Say

The public floods FDA with hundreds of comments urging the agency not to change its regulations to allow hearing aids to be sold over the counter.

Marie Thibault

Hundreds of comments have poured in from the public and hearing specialists voicing their opposition to the suggestion that some hearing aids be made available over-the-counter (OTC).

Hearing aids have become an especially hot topic after a September 2015 report from the President's Council of Advisors on Science and Technology (PCAST) recommended that FDA create a new "basic" category for hearing aids and hearing tests to be sold OTC. PCAST made this suggestion against the backdrop of low penetration of assistive hearing technologies among the population that needs it, citing factors like high cost and barriers to access. The council also recommended that FDA repeal its 2013 draft guidance on Personal Sound Amplification Products (PSAPs) to allow these to be labeled for age-related mild-to-moderate hearing loss and asked the Federal Trade Commission (FTC) to facilitate a hearing-aid prescription process that would allow consumers more flexibility in choosing a device, service, and dispenser.

FDA reopened the comment period on that 2013 PSAP draft guidance at the beginning of this year and also held a public workshop on "Streamlining Good Manufacturing Practices for Hearing Aids" in April 2016. The agency also opened the topic to public comments—that comment period closes June 30.

Following the PCAST report, Judith Page, PhD, CCC-SLP, president of the American Speech-Language-Hearing Association (ASHA) sent a letter to the council chairs expressing concern that the recommendations focused only on the amplification device. She wrote, "A common misconception that was evident in the PCAST report is that amplification alone will enable a person with hearing loss to hear and understand fully in the same manner that glasses can restore normal vision. A hearing aid alone is not enough to overcome a hearing disability. Treatment for hearing loss is more complex and requires a comprehensive assessment of the patient’s needs in addition to a detailed evaluation of auditory function beyond the simple audiogram—areas of expertise that audiologists have specialized training to do."

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People who submitted comments to FDA tried to impress upon the agency the importance of the hearing professional's role in helping the patient. 

The majority of comments were from people who submitted a form letter that explained their belief that: 

  1. "The lay person is unable to reliably self-diagnose, self-evaluate, and self-treat hearing loss. 
  2. Most PSAPs are potentially dangerous to the hearing health of consumers due to having a maximum output that is too high.
  3. Most PSAPs lack the features to produce any benefit for the number one reason people seek assistance: speech understanding in noise."

These commenters concluded, "For these reasons, the creation of an OTC category that allows PSAPs to be labeled and marketed as hearing aids would be a huge step backward in technological sophistication and would lead to less customer satisfaction, lower adoption rates, and higher health care costs."

One commenter, a long-time hearing instrument specialist, was straightforward in his opposition to the PCAST recommendations. He wrote, "I know the care and concern it takes to properly fit Hearing Instruments, and the ongoing care that they require. For this reason I am strongly opposed the PCAST recommendation to relax the requirements and laws on the way hearing aids are correctly fit. I urge the FDA to reject the proposals."

Where will the issue go from here? More work is being done on the topic, but the winds seem to be blowing in the direction of OTC hearing devices. The Institute of Medicine, along with several agency cosponsors, including FDA, recently released the results of its study on accessible and affordable hearing health care for adults, which included a recommendation that FDA create a category for OTC hearing devices.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter@medtechmarie.