Over the Counter Hearing Aids

By September 17, 2021September 29th, 2021No Comments

What are over-the-counter (OTC) hearing aids?

In 2017 Over the Counter Hearing aid Act was signed into law and was to go to the FDA for clarification of regulations which included 1) reasonable assurances of safety and efficacy 2) establish output limits and labeling requirements and 3) describe requirements for the sale of hearing aids in person, by mail or online without a prescription. This was not accomplished and in 2021 Senators Warren and Grassley called out the FDA on why the regulations were not accomplished. In July 2021 President Biden released an Executive order on OTC hearing aids. As of right now, only a select few companies can sell OTC products, Bose and Jabra being two. Many other OTC hearing aids are not legal to sell and many Attorney General’s offices across the nation, Arizona’s being the first, to warn consumers of misleading sales. OTC hearing aids are coming and are in theory (because the regulations have not been written) for only those who have a mild to moderate self reported hearing loss. Many people wait 7 to 10 years before they seek help with amplification and this law is to in theory give better access to amplification and a lower cost. These hearing aids can be self fit. Bose has these available now in States that allow (which is 5 at this time) the sales, for $850 and uses the users responses within an app to self tune. The clinical trials have been quite positive for Bose. Again, these aids are not for severe to profound hearing loss, nor for anyone under the age of 18. The challenge is and will continue to be that hearing loss is usually so gradual that individuals have a difficult time knowing when they should seek help. OTC hearing aids might be a great first step in getting people the help they need. When the degree of hearing loss becomes moderate to severe though, an Audiologist should be involved in the hearing aid fitting process.

Who can benefit from over the counter hearing aids?

Anyone over the age of 18 could benefit from OTC hearing aids. It is critical to note OTC will never be appropriate for children. An Audiologist will still be required to best fit kids due to the medical nature, community, state and federal support and being part of the medical team needed to best care for those under 18. Children must have a medical clearance for hearing aids provided by a physician, and in most cases should be an ENT. OTC hearing aids are for those experiencing mild hearing loss and possibly some moderate types. When the professional is taken out of the process then simple to complicated medical issues are often missed. These include asymmetrical hearing loss, when one ear is better than the other, as a specialist in the auditory system we need to know and understand why. We see many hunters and military service members who have hearing loss worse in the left ear and we almost always know it is because they are a right handed shooter. But there are times the in-between ear difference can be due to a tumor on the auditory nerve in very rare cases. Hearing loss can come from something as common as ear wax! Not all medical professionals know as much about ear wax as an audiologist! We are the most knowledgeable about the types of wax and when it needs to be removed. There can be middle ear issues that need medical attention. OTC is supposed to refer to a specialist if there is a difference between the ears, but we have already seen this does not always happen. Bone conduction testing is never done with OTC, nor looking in the canal. But one can always have their hearing exam done and still purchase OTC. Moisture and earwax are the most common problems with any electronic that goes in the ears. Oro Valley Audiology has a Redux system that can vacuum out AirPods, to OTC, prescriptive and custom hearing aids. We can keep them running and the charge is $35.

Over the Counter Hearing Aids: Not for Severe Hearing Loss

Over-the-counter hearing aids are specifically designed for mild to moderate hearing losses. Those individuals who suffer moderately severe to profound hearing loss should not be obtaining hearing aids directly through the Internet. Oro Valley audiology incorporates best practices and excellent medical care by exploring medication usage, health issues such as diabetes and dementia, and verifies the hearing aid function with real air measurements, none of which you can get through an online company.

Over the Counter Hearing Aids Regulations

As of now there are no regulations surrounding over-the-counter hearing aids. The FDA must produce guidelines and needs to follow a process set by our government. We are hopeful that the hearing aids have just enough power to help those with mild to moderate hearing losses. If they happen to be more powerful than that this can cause a noise-induced hearing loss on individuals who do not have the hearing aid monitored by a professional. Once the FDA has created the regulations it must be open to the public for comment and as of September 2021 this has not happened.

Over the Counter Hearing Aids and PSAPs

We do get asked the difference between OTC, over-the-counter hearing aids and PSAPs, which stands for personal sound amplification. The main difference is PSAPs have not been cleared by the FDA To be called a hearing aid. They are purely amplifiers of sound, where as OTCs will take more of a prescription and use algorithms to amplify where the hearing loss is most prominent. Both of which if misused could cause a noise-induced hearing loss if not monitored.

Why are OTC hearing aids becoming available now?

OTC hearing aids are now becoming available as of 2017 the bill was signed into law by Pres. Trump but the FDA never set the regulations. Many companies started to work on OTC hearing aids waiting for their approval and Pres. Biden made an executive decision to have them released in the summer of 2021. As of this writing in September 2021 two companies have OTC clearance and that is Bose and Jabra. There will be many direct to consumer sales of over-the-counter hearing aids in the coming years.

Over the Counter Hearing Aids: From an Audiologist’s POV

Working in audiology for 30 years I have seen extraordinary technological changes surrounding hearing aids. We work in audiology because we want to help every person if they have a damaged auditory system, and hearing aids are a small part of this. The frustration of a long-standing audiologist in the industry I have seen too much emphasis on the widget. If every single audiologist knew what’s best for the patient, their lifestyle, and verified with real ear we would be in a much better position at this time. There are many audiologists that are nervous about OTC hearing aids coming into the market. But there is a marked difference in counseling for tinnitus, auditory processing, and balance disorders from a live person and somebody on the other side of a chatbox or telephone. The longer a person waits to seek help for their hearing loss the more difficult the fitting will be. If OTC hearing aids gets people to seek help faster than I would call this a win for audiology.

Over the Counter Hearing Aids Pros and Cons

As an audiologist I know there is so much more to explore and diagnose beyond a simple audiogram, unfortunately many professionals do not go beyond this basic test. If more audiologists did a functional hearing assessment, speech and noise testing and processing disorder tests they would have a much broader picture to better serve their patients. All of this is our philosophy at Oro Valley audiology. I am concerned that those with a more significant hearing loss or parents with children with hearing loss may purchase direct to consumer or OTC hearing aids through the Internet never seeing an audiologist, therefore medical diagnoses will be missed. Many audiologists have stories of how the referral changed a patient’s life and saved their life. Earwax removal is easy for us and sometimes a hearing aid is not needed after This procedure. But there have been times we’ve referred and tumors have been found and unfortunately I do not feel these things will be caught with OTC amplification.

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