Over-The-Counter (OTC) Hearing Aids


The Over The Counter Hearing Aid Act (H.R. 1652) was approved in August 2022, allowing the FDA to create a new classification of hearing devices. The intent of this act is to improve access and affordability of hearing aids. In reality, direct to consumer hearing devices have been on the market for several years, but had not been regulated by the FDA for safety, reliability and consumer protection. These hearing amplifiers are designed for adults age 18 and older with “perceived” mild to moderate hearing loss and can be purchased over the counter (directly in stores or online). No hearing exam is required and there are no professional services included.

What is an OTC Hearing Aid?

  • They provide amplified sounds for adults 18 years or older with “perceived” mild to moderate hearing loss.
  • They have limited output for safety and will not provide adequate audibility for more than a moderate hearing loss.
  • While they may look similar on the outside, OTC hearing aids have limitations in programmability, style and features. Some OTC’s have preset “programs” for varying levels of hearing loss and others have a volume control or bass/treble equalizers.
  • They are intended to be worn like store-bought reading glasses.

Will OTC Hearing Aids Help Me?

OTC hearing aids may be a good fit for you if:

  • You are 18 years or older with a mild to moderate hearing loss.
  • You are confident in selecting an appropriate device and fitting your device.
  • You are able to manage an app.
  • You do not have any medical red flags (ear infections, ear pain or pressure, drainage, dizziness, sudden hearing loss, tinnitus (ringing) in one ear or excessive earwax build up). 
  • You do not struggle in quiet situations; this usually indicates a severe hearing loss.

Though a hearing test is not required to purchase OTC devices, we strongly recommend it. During your hearing evaluation, a licensed and board certified Audiologist can diagnose your exact degree and type of hearing loss. Most health insurance plans also cover this testing! We also take a thorough case history to determine if there are any medical conditions that should be treated by an Ear Nose & Throat physician.

How do OTC and Prescription Hearing Aids Compare?

OTC vs Prescription Hearing Aids
OTC Hearing Aids Prescription Hearing Aids
$200-1500/pair $2400-6150/pair
Chosen and fit yourself Choice guided by Doctor of Audiology and fit by Audiologist
Basic fit and styles provided Discreet and custom options based on your ear, hearing loss, and needs
Preset or limited programming Fully programmable by Audiologist
No verification of output (volume) at any pitch Output verified to your exact prescription, at every pitch, by Audiologist
No follow-up care, orientation or training to use device Personalized counseling, fine tuning and follow-ups for up to 3 years (without office visit fees)
Features for standard amplification Advanced features and technology to meet individual listening needs
Limited to mild to moderate hearing loss For all severities of hearing loss; mild to profound


At OHSU Audiology, we believe that hearing outcomes are best achieved with evidence based practice and when professional service is provided along with the device. We offer fully programmable, prescription based hearing aids and we are eager to help you choose the appropriate hearing aid that fits your lifestyle and hearing needs.  We are committed to the full spectrum of hearing technology and our options may surprise you! If you are considering OTC hearing aids, ask your audiologist whether your hearing loss fits the criteria.

Make an appointment with one of our audiologist for a hearing evaluation and see if your current devices are providing you the best hearing.

OHSU Marquam Hill   503-494-5171 (insurance accepted)

OHSU SoundSource    503-418-2555 (self-pay only)