Groups seek to shape final rule to make hearing aids easier to access


Kate Carr, president of the Hearing Industries Association, a trade group representing manufacturers, suppliers, distributors, and hearing care professionals of hearing aids, wrote in a comment letter that the FDA should take additional steps to ensure the safety and efficiency of over-the-counter devices.

“Patients will get no real benefit from easier access to hearing aids that are unsafe or ineffective,” Carr wrote. “And, to increase access in a way that meets FDA and Congressional goals, patients must be able to rely on design features and labeling to select, then safely and effectively use and maintain over-the-counter hearing aids.

Several groups have also filed comments on the labeling requirements for these hearing aids. The ASHA recommends that labels recognize the value of consulting a hearing health expert before using any type of hearing aid.

The HLAA said it supports the FDA’s proposed labeling requirements, but labels should also clearly indicate whether a patient would need complementary technology, such as a smartphone, to use a hearing aid or whether the device is compatible with wireless devices, among other things. The group is also pushing for this information to be in large print, given that many hearing-impaired Americans are over 65 and may also have low vision.

The Hearing Industries Association, led by Carr, said outer labels should provide more examples of mild to moderate hearing loss. They also recommend that the outer label advises the patient to return the device and seek professional help if it does not work for them.


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