OTC Hearing Aid Act Moves Ahead

On Friday May 12, a Senate bill containing a provision for FDA-approved Over the Counter Hearing Aids passed from committee to the full Senate, where it is expected to pass.

This is an enormous step towards cheaper, more accessible hearing aids, which should help lower the cost of all hearing aids, even high-end hearing aids, which can now cost up to $6000 each, and which average about $2400 each.

This is an important bill, in my opinion, and in the opinion of other advocates for people with hearing loss, including the Hearing Loss Association of America. For more on this, see my previous post, What Exactly is an Over the Counter Hearing Aid.  The comments, especially one from Ben Kaufman, are also informative.

Here’s an article from Modern Healthcare on Friday’s committee vote:

“FDA User-fee Extension Breezes Through Senate Committee.”
The act, which calls for more than $400 million in additional user fees to be collected from the makers of prescription brand drugs, medical devices, generic drugs and “biosimilars” looks to expedite new drug approvals. The committee added amendments aimed at increasing competition.  READ MORE

8 thoughts on “OTC Hearing Aid Act Moves Ahead

  1. I have major misgivings about this. No insistence on telecoil. No training to “vet” or refer unilateral hearing loss or screen for major medical issues. Focus needs to be on changing law, adding hearing loss. If this goes through, no incentive for insurance companies to add heating loss to covered benefits.


    • Well, we actually don’t know what the FDA regs would say. I do know that there will be prominent warning labels about red flag conditions that could indicate important medical issues.
      As for telecoils, many audiologists don’t even tell their patients they are an option, and even when patients ask they may be told that they don’t need a telecoil. I think a telecoil is an essential part of a hearing aid, but someone with mild to moderate hearing loss might not agree — especially if they can hear well on the phone, don’t need assistive devices, don’t have access to looping or assistive listening systems like FM or IR.


      • People with mild/mod hearing loss often a hear background EMI at audible and distracting levels when they use a telecoil…especially in environments where background noise levels a low…as in church, a theatre or lecture. The EMI is like a constant tone tinnitus at 60Hz and it’s harmonics.


      • I get that but only when the hearing aid is set to the telecoil program. If I switch it off, the buzz dgoes away. It is a flaw though, I agree. It makes talking on my cell phone on a city street impossible. Too much buzz.


  2. Without doubt, this bill is a step in the right direction. And, I agree that the T-Coil is an essential tool that is woefully underrated by most audiologists. They can’t make a lot of money dealing with it. Neither can they make a lot of money dealing with OTC HAs. The ground rules for this new “game” have yet to be worked out. What is tremendously exciting is that hearing loss and the many forms of its treatment is finally being talked about.


  3. Although the formation of this bill has been a wonderful tool to increase awareness to this problem, the bill is completely unnecessary. General Hearing Instruments has been manufacturing FDA Regulated, direct to consumer hearing aids (NOT PSAPS) for over 10 YEARS. These hearing aids are for people with mild to moderate hearing loss (approximately 25 million people) . They are made of the same quality components as those purchased from an Audiologist/ENT but are a fraction of the price. ( Less than $1000/pair compared to the average price from medical model of $5000/pair). Our distribution network includes the following companies: walmart.com, samsclub.com, pricesmart.com, staples, com, AAFES, sears.com, etc.

    FYI: PSAP manufacturers choose to use these semantics (name games)to avoid FDA regulations ensuring quality of the build and avoid the requirement to reserve a device medical history record. Also be cautious of those within the hearing industry “assisting” the formation of OTC classifications. There are many that believe this is a Trojan horse. Rumors have been swirling that these groups only focus is to put limitations on these devices that will make them completely ineffective, thus preserving the medical model.

    In summary, there is a huge need for economical hearing help, but additional legislation is not the answer. If interested in more info, you can contact us 1-800-824-3021


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