Researcher fights FDA for over-the-counter hearing aids
Dr. Mead Killion, a researcher in the hearing aid field who runs Etymotic Research, is fighting the Food and Drug Administration to be allowed to develop and sell an over-the-counter hearing aid for mild-to-moderate hearing loss.
Under the Hearing Aid Rule of 1977, consumers must be screened by a physician or sign a waiver administered by a state-licensed hearing-aid specialist before obtaining the device.
In August, Killion and his wife petitioned the FDA to eliminate this requirement. The FDA in February rejected Killion's petition, citing concerns that 'red flag' ear conditions will go undiagnosed and unevaluated. Killion has submitted another petition to the agency for a new "one size fits most" category of hearing aids.
Hearing aids are not covered by Medicare or most private health plans and cost an average of $2,000 each, according to the Wall Street Journal. Killion says that an over-the-counter hearing aid could be sold for $100.