FDA Backs Selling Hearing Aids Over the Counter

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The U.S. Food and Drug Administration (FDA) just announced it is taking steps to make hearing aids available over the counter. In this regard it will function in a manner similar to reading glasses. The FDA plans to immediately stop enforcing a requirement that patient have a medical evaluation prior to obtaining a hearing aid. The Agency also hopes its move will stimulate a new category of OTC hearing aid products that cost less.

According to information gathered by AARP the average cost of an individual hearing aid $2,300 with a pair costing double that amount. Of that, retailer costs (which included patient training and education) can run $2,236 for a pair of hearing aids.  A trip to the otolaryngologist, who might arrange for the services of an audiologist to administer a hearing test might set you back $250 to $400.  A blog post by Embrace Hearing suggests the bundled price — when patients over-pay for hearing aids but get free services — may be equivalent o paying $1,000 a visit for the services of a technician to adjust a hearing aid. Of course this all depends on the number of visits you need.

The price for hearing aids, hearing tests, hearing aid adjustments and training will likely fall once the requirement to have a medical evaluation is no longer enforced by the FDA. Moreover, I foresee some web-based purveyors assisting patients with hearing tests and helping then adjust the aids.

There will always be a need for in-office visits to an audiologist for hearing tests and assessments. However, when the visit is voluntary rather than required by law, providers will be free to innovate with new service arrangements and compete for patients’ business. The FDA also needs to work with would-be hearing aid designers to streamline the process of getting approval (i.e. 510(k) premarket notification) to sell cheaper, over-the-counter designs.

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