One way or the other, it looks as if Over-the-Counter hearing aids will come on the market in the not too distant future.
In March, Senators Elizabeth Warren (D. Mass), Chuck Grassley (R. Iowa), Maggie Hassan (D-N.H.), and Johnny Isakson (R-Ga. reintroduced their bipartisan Over-the-Counter Hearing Aid bill.
On May 2, the House Energy & Commerce Subcommittee held a hearing on the proposed “Over-the-Counter Hearing Aid Act,” H.R. 1652, co-sponsored by Representative Marsha Blackburn, a conservative Republican from Tennessee, and Joseph Kennedy (D. Mass).
And now the Food and Drug Administration, which regulates the sale of hearing aids, looks like it may make legislation moot. The agency is expected to make an announcement in the near future about whether or not it will approve OTC hearing aids.
What exactly is an over the counter hearing aid?
We already have a device available over the counter that corrects hearing loss. What is it if not an OTC hearing aid? It’s a PSAP, a Personal Sound Amplification Product, which can cost anywhere from $50 to $500. A PSAP can only be marketed as a sound amplifier for people with normal hearing..
So what’s an OTC hearing aid? Right now it’s a concept, not a product.
An OTC hearing would probably do pretty much what a good PSAP already does, but with FDA approval. It would be a digital device, possibly with directional microphones, Bluetooth and a telecoil, and presumably it would cost $1000 or less. An OTC hearing aid could be sold direct to the consumer, without an audiologist or hearing aid dispenser involved.
An OTC hearing aid would be subject to FDA safety and efficacy standards. Most consumer activists support this initiative, as a way of getting people to correct their hearing loss. OTC hearing aids are not for people with severe hearing loss, single sided hearing loss, or hearing loss caused by a number of medical conditions. So why do I, who can never benefit from an OTC aid, support it?
Four out of five older Americans with hearing loss decide to ignore it, so clearly something needs to change. Many of these people cannot afford hearing aids or worry about stigma. More widespread hearing devices of all kinds would help with both those issues.
Competition will bring prices down. Ubiquitous use will end stigma. Lower prices, end stigma. What’s not to like?
Addendum, 9:30 pm Weds May 10: It looks like a done deal.
WASHINGTON, D.C. — Members of the American Academy of Audiology (AAA) and International Hearing Society (IHS) learned yesterday afternoon that the Over-The-Counter Hearing Aid Act legislation has now been attached to the Medical Device User Fee and Modernization Act (MDUFA). According to AAA President Ian Windmill, the MDUFA bill is considered “must-pass” legislation and is scheduled to be voted on today in the assigned Senate committee.
Because the current OTC hearing aid legislation has sponsors from both political parties, and now that it has been attached to a must-pass bill, the likelihood of passage has increased significantly.