Up until recently, a ‘hearing aid’ was an FDA approved medical device sold and programmed by an Audiologist with requirements for an in-office evaluation, customized fitting and mandatory trial period . These devices passed rigorous safety and reliability standards, are often sold with a service package including 12-48 months manufacturer warranties as well as in-office fitting, verification and follow-up appointments.
In October 2022 the FDA created a category called “OTC hearing aids” which are regulated medical devices that can be purchased without a hearing exam, prescription, or appointment with an Audiologist.
Some big name players like Sony and Bose are jumping in to the market, in addition to smaller companies who previously sold their devices as PSAPs (personal sound amplification devices).
Could an OTC hearing aid be right for you?
OTC hearing aids are intended for:
- Age 18+
- Perceived mild-to moderate loss
- Come in ‘over-the-ear’ or ‘earbud’ one size fits most style units, are generally sold in pairs
- Will not pick up medical issues, wax or asymmetry
- May or may not be sold with trial period
- Warranties and prices vary
- OTC hearing aids are probably not eligible for funding such as ACC, Veteran’s Affairs or the NZ Hearing Aid Subsidy
Do you want some advice from an Audiologist?
If you are new to hearing aids and starting to notice problems with your hearing – have a proper evaluation at your local audiology clinic.
Studies show people underestimate their own level of hearing loss – hearing generally deteriorates gradually making it difficult to self-assess.
In a full hearing evaluation, the Audiologist will check your ears for wax and medical issues, tell you if you have hearing loss and to what degree, whether there is asymmetry (significant difference in hearing between your ears), and whether hearing aids (custom fitted and/or OTC) are recommended. If you want to research OTC devices from there at least you’ve got a good baseline and you’ve ruled out wax and medical issues.
Many Audiology clinics carry OTC products, offer free trials or can recommend some good quality OTC brands.
This article was written by Teresa Burns, AuD, MNZAS, Doctor of Audiology and Director of Teresa Burns Hearing Ltd, in Auckland, New Zealand. For more information or to contact Teresa check out her website at https://www.newzealandhearing.co.nz/teresa-burns-hearing/
For more articles from Teresa about hearing, click here