Over-the-Counter hearing aids
  • Oct 8, 2020

Over-the-Counter hearing aids

Updated January 2024

A new category of over-the-counter (OTC) hearing aids has been established by the U.S. Food and Drug Administration (FDA) in August 2022. It is called the Over-the-Counter Hearing Aid Act.

October 19 2021 - "the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans."

Many hearing aids can be expensive. The rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturers.

There are personal sound amplification products, the idea is that the FDA would "clean up" or force them into a regulated market, rather than the claims like-:

"hear 50 times better"

One of the claims from a US $30 device, which is obviously garbage and earnt the company a Federal Trade Commission (FTC) law suit involving millions of dollars, which settled for much less.

In general with over-the-counter product right now amplifier that's not called a hearing aid, you can't say that you're going to help with hearing necessarily, especially hearing loss.

A test of personal sound amplification products (PSAPs):

Some PSAPs you can use a smartphone app to customize exactly what frequencies are being raised where.

When compared with a popular hearing aid in one clinic some of the devices were close to the same improvement (simple tests) and others were way off, no where near the benefit of a hearing aid.

However junk PSAPs will amplify low frequency sounds with a lot of distortion - absolutely useless, making it harder to hear.

If you have a lot of high-frequency loss and you just blast low frequencies, you actually mask out the rest of sound as a user. So for that group, they, they actually, on average did worse. PSAP Advertisement

Early Entry into Hearing Aid Market

Numerous credible studies have shown hearing aids help prevent/delay dementia.

The notion of use your hearing or lose it is simply common sense. Hence the introduction of a PSAP as long as it is regulated to prevent damage to ears and is simply not a poor quality gimmick would help say a 60 year old with a mild loss, to use to hear a TV. The early intervention could have positive long-term health effects.

In Australia, the average man diagnosed with hearing loss will take between 7 and 10 years to act on it.

Also it is important as a person with mild hearing loss, to use good quality devices like telephones, iPhones, noise cancelling headphones and good quality speaker systems if you can.

Price can be a barrier, especially in Australia. Fortunately mobs like Hearing Aid Prices the first company to show comprehensive prices for hearing aids, also provide great fittings and care.

The advanced features, quality, comfort and longevity of modern hearing aids really make them the go to option.

Deciding to intervene early in your hearing loss, may make a huge quality of life difference.

Early Entry Hearing-Aids

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Recommended OTC devices 2023

Sony CRE-C10

Hearing Tracker recommended the Sony CRE-C10. This is an invisible device the same size as a Signia Silk X hearing aid.

The Sony CRE-C10 only comes in black. That is the ideal colour for a discrete Invisible in the Ear Hearing Aid as it matches the hole of your ear canal.

These devices are advertised for those with mild to moderate hearing loss. However it is recommended even if you do end up with an OTC device, to get professionally assessed by an audiologist.

People often under estimate the extent of their hearing loss.

"Automatically analyzes, adjusts, and optimizes sound based on where you are."

Note an OTC hearing aid would not have the capability of a top of the range prescription hearing aid. Sony CRE-C10 does have some impressive features.

Eargo 7

Hearing Tracker recommended the Eargo 7

Sound Adjust + is their noise management feature. However it is recommended even if you do end up with an OTC device, to get professionally assessed by an audiologist.

There is an app that allows you to adjust your settings.

Sennheiser Conversation Clear Plus

Although this device is not classed as an OTC Hearing Aid it has many 'Hearing Aid' features like-:

  •   Advanced speech enhancement
  •   Adjusts to surroundings with automatic scene detections
  •   Noise cancellation
  •   Ambient awareness
  •   Conversation Clear App
  •   Connect to any Bluetooth device
  •   High sound quality
  •   Hear clearer during calls with speech enhancement and active noise cancellation

Sennheiser Conversation Clear Plus

With a choice of small, medium or large interchangeable tips, they should fit comfortably in your ear. Voice assistants (eg Siri, Google Assist) are available with a double tap of the ear.

They are not classified as self-fitting with 3 modes-:

Relax Mode when you are not looking at enhancing speech
Communication Mode listening to someone in front of you
Streaming Mode streaming media or taking phone calls

Battery Life

9 hours battery life. The case itself is a battery pack (2 extra 9 hour storage).

Occlusion Effect

Often people with hearing loss have a sloping away of the high-tones. This can cause an 'Occlusion Effect' which feels like you have your fingers in your ear. Your voice can sound 'boomy'.

Would you wear this in company?

Sony C10 Self-Fitting OTC Hearing Aids

Sony state the devices are suitable for people with mild to moderate hearing loss. Some of the features include-:

  •   Fits discreetly inside the ear canal for a virtually invisible look
  •   Easy to setup and customize your hearing with the Sony | Hearing control app
  •   Delivers prescription-grade sound quality making every experience crystal clear
  •   An FDA-registered medical device developed with WS Audiology
  •   Comes with four sleeve sizes designed for comfort and ease
  •   Automatically analyzes, adjusts, and optimises sound based on where you are
  •   Quality noise reduction and focused microphones for better hearing in environments with background noise
  •   Delivers up to 70 hours of continuous use with size 10 batteries

Air Pods with iPhone

AirPods Pro 2

Apple's latest AirPods with the H2 chip are not technically hearing aids, nor are they marketed as such. However they have many hearing aid qualities and a prominent Audiologist reviewed them. Features like Active Noise Cancellation and Noise Reduction are similar to modern hearing aids.

Any technology that allows you to hear better is a bonus. Here are some major points-:

  •   Sample sound at 48,000 times per second
  •   Battery life of 6 hours
  •   Transparency mode (hear the world around you through the headphones)
  •   Deal with background noise
  •   Streaming and Phone calls

To transform AirPods Pro 2 into "hearing aids"-

  •   Take a hearing test and upload your audiogram
  •   Update audio accessibility settings
  •   Turn up the transparency mode volume on the AirPods

Bose Releases Self-Fitting Hearing Aids

May 2021

Bose state they are the first with clinically proven self-tuning through their App.

Bose pursued its own classification with the US Food and Drug Administration (FDA)

Self-fitting air-conduction hearing aid.

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.
FDA US Food and Drug Administration

Limitations compared to a Hearing Aid

If you compared the Bose Sound Control Self Fitting Hearing Aids to a top of the range Phonak Audeo Paradise Rechargeable Hearing Aid there would be significant differences.

  •   Non Rechargeable
  •   Cannot Bluetooth® phone calls
  •   Noise reduction
  •   Directionality
  •   Automatic Hearing Programs
  •   Feedback Reduction

However although the Bose SoundControl™ Self Fitting Hearing Aids lack the sophisticated features of an advanced hearing aid, they would be a significant improvement for those with a mild hearing loss at a reduced cost.

What's in the box Video

SoundControl What is in the box Video

Connecting to a Bluetooth® Device Video

Sound Control Connecting to a Bluetooth Device Video

Bose QuietComfort® Earbuds

As a wearer of hearing aids, I was interested in how the Bose QuietComfort® Earbuds compared to a set of high quality hearing aids.

These devices are not hearing aids, however a person with mild to moderate hearing loss can really benefit especially when streaming audio in a noisy environment. The noise cancelling works well and allows you to adjust levels. You will notice the weight compared to a hearing aid. The sound is robust and clear. It would have been nice to be able to adjust treble or base to get a sound better suited to your hearing loss.

Olive Pro Hearing Earbuds Review

September 2021

Watch the full review to get a better understanding of how a hearing professional rates the Olive Pro Hear + Music + Care Earbuds.

The Olive Pro is an FDA registered hearing aid (class II medical device).

SoundControl What is in the box Video

Points at a glance-:

1 There are issues with the accuracy of the hearing test partly due to the fit (perhaps leaking in external noise)

2 The bass sound is lacking perhaps due to the attempt to reduce occlusion (where your own voice sounds strange and you feel like you are all blocked up)

3 The app has some good features like being able to set the EQ - hence these Eardbuds could be dialled in to work really well at home watching TV

4 A battery life of 7 hours is not going to last all day, however this device may not be comfortable all day.

5 The 6 major hearing aid companies do an incredible job. The comfort level of hearing aids is such that you really do not notice you are wearing them.


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