Over-the-Counter Hearing Aids Go into Effect, New Designs Follow Suit

October 17, 2022 by Chantelle Dubois

As of today, users can buy over-the-counter hearing aids online and in-store, inspiring medtech companies to mobilize new design efforts.

The U.S. Food and Drug Administration (FDA) recently issued a final ruling to make over-the-counter hearing aids accessible to millions of Americans experiencing hearing loss. 

This means that soon it will be possible for Americans to purchase conductive hearing aids without a prescription or fitting by an audiologist from retailers. This is expected to make hearing aids more affordable and accessible to those who need them.


OTC hearing aid legislation

The OTC hearing aid legislation went into effect today, October 17, 2022.


The policy to create a category of over-the-counter (OTC) hearing aids was first legislated in 2017, but it wasn’t until the FDA received an executive order to act on the legislation within 120 days that a final ruling was issued in August 2022. The ruling includes guidelines on device classification/markings, labeling, technical specifications, and conditions for OTC sales. 

The World Health Organization (WHO) projects that by 2050 there will be nearly 2.5 billion people globally who will experience hearing loss. Of those, nearly 700 million will require some form of hearing rehabilitation. That translates to nearly 1 out of 10 people with hearing loss requiring rehabilitation. 


The History of Hearing Aids 

In the past, the size of hearing aids discouraged some users from adopting these devices. In the early 1900s, miniaturization of the vacuum tube gave rise to the Vactuphone, the first vacuum tube hearing aid commercially produced. The Vactuphone was about the size of a 1920s camera case and comprised a 205-A peanut tube and two batteries: a 1.5 V No.6 dry cell battery and a 24 V battery. In 1921, the Vactuphone sold for $135 USD, which translates to approximately $1,940 USD in 2022. 



The Vactuphone was the first vacuum tube-based hearing aid to go to market. Image used courtesy of Hearing Health Matters


Improvements both in hardware and software have made modern hearing aids more convenient and effective. Battery technology, for instance, is now smaller and rechargeable. The invention of the transistor also enabled smaller hearing aids. And directional microphones focus which sound is being amplified. 

Today, hearing aids can be quite small, depending on the category of hearing aid and the user's kind of hearing loss. Some of the smallest devices fit within the ear canal, making them mostly hidden from view and non-obstructive for the user. Modern hearing aids can cost anywhere from $800 USD to nearly $8,000 USD.


Phonak Lyrics hearing aid

The Phonak Lyrics hearing aid is marketed as an “invisible” device. Image used courtesy of Phonak


Recent Innovations in Hearing Aid Technology

Hearing aids have undergone a performance evolution as well—most recently affected by advances in artificial intelligence. 

One recent example comes from the University of Glasgow, which is investigating how to complement hearing aid devices with lip reading using radio-frequency signals and deep learning algorithms. The system can detect when a speaker forms vowels—even when the speaker is wearing a mask since the mask does not impede radio-frequency signals. 


RF-based lip-reading system

Working principles and applications of the RF-based lip-reading system. Image used courtesy of the University of Glasgow


Other researchers are focusing on ear mechanics to improve hearing aid devices. From the University of Rochester, a research group is studying the inside of the inner ear called the cochlea to identify the moment when air vibrations are converted into neuro signals to the brain.

The philosophy of the Rochester group is that each individual using a hearing aid is unique, so the best solution to compensate for that loss will be different for each person. In particular, the group wishes to use optical coherence tomography to study cochlear tissue. Optical coherence tomography is widely used in the field of ophthalmology to study the retina in the eye and works similarly to ultrasound; however, instead of bouncing sound waves off of live tissue, it bounces light waves off tissue to create imagery of the different tissue layers.


Sony and WSA Team Up for Commercial OTC Hearing Aids

Shortly after the FDA ruling, Sony and WS Audiology (WSA) announced a partnership to start developing over-the-counter hearing aid devices for the U.S. market. 

Sony has a successful catalog of audio systems ranging from high-end headphones with advanced noise canceling to home entertainment systems, while WSA is well positioned in the medical hearing aid sector. 


Hearing aid adoption rate in the U.S.

Hearing aid adoption rate in the U.S. Screenshot used courtesy of Sony Global


Under Sony's brand, the two companies are co-developing the first product following the FDA's final ruling on OTC hearing aids without a prescription. This legislation went into effect today, October 17, 2022.

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