Lynette L. Dornton, Au.D.

Sharon Rende, Au.D.

Over-The-Counter (OTC) Hearing Aids Demystified

Presenter Disclosure:

• Financial: Clinical and Research Audiology at Silverstein Institute First Physicians Group. Dispensing Audiologist at Concierge Hearing Devices, LLC.
• Non-Financial: Member of the American Academy of Audiology and the American Speech and Hearing Association. Serve as Audiology Consultant for the Ear Research Foundation
• Content: This presentation does not advocate for any specific product or service model and any opinions expressed are those of the presenter alone.

Talk Objectives:

• Define OTC Hearing Aids
• Explain the difference between traditional prescribed hearing aids and OTC devices
• Examine what determines patient success with amplification. Type of Instrument, Provider, or Both?
• Help attendees determine if OTC Hearing Aids may be appropriate for themselves or a loved one

​

​

​

​

Why do we need a talk like this?

• Confusing and rapidly evolving legal and regulatory landscape

​

• Abundance of products on the market with little regulatory oversight

​

• Essentially no UNBIASED information for patients and consumers

​

​

​

​

What is an Over-the-Counter Hearing Aid?

OTC Hearing Aid Legislation

• Over The Counter Hearing Aid Act of 2017
• Cosponsored by Elizabeth Warren and Chuck Grassley
• Goal is to make amplification more affordable
• Adults with “Perceived Mild to Moderate Hearing Loss”
• Direct to Consumer-
• “without supervision, prescription, or other involvement, or intervention of a licensed professional”
• Federal Law preempts state and local laws

​

​

​

​

​

• Short bill with very few specifics
• FDA given 3 years to figure out all the details
• August 2020 passed without any updates….
• We have been waiting for the FDA to fill in the gaps
• Uproar from Hearing Healthcare Professionals
• Unscrupulous advertising of products labeled as “OTC”
• Confusion among those with hearing loss

​

​

​

​

​

​

​

OTC Hearing Aid Act of 2017

Traditional Hearing Aid Regulations

• Hearing Aids

• PSAPS
• Personal Sound Amplifier Products

• FDA Regulated Medical Device

• Can Make Medical Claims

• FDA “Recognized” Category

• CANNOT Make Medical Claims

New Hearing Aid Regulations

• Hearing Aids

• Traditional Hearing Aids

• Over The Counter Hearing Aids

Brick and Mortar

Big Box Stores

Internet

FDA Released Proposed Guidelines for OTC Hearing Aids- October 19^th 2021

• OTC devices will have to obtain 510(k) FDA Clearance
• ANY product claiming to “treat hearing loss” will have to have this clearance
• Potential for more transparent advertising and marketing if enforced
• Defines Technical Specifications:
• Frequency Range, Output Limits, Distortion etc…
• Design Requirements:
• Atraumatic Materials, etc…

​

​

​

​

​

​

​

​

​

October 19^th 2021 FDA Released Proposed Guidelines for OTC Hearing

​

​

• Who are OTC hearing aids designed for?
• Persons with mild to moderate “self perceived” hearing loss
• Adults 18 years of age or older

​

​

​

​

​

​

​

​

​

Who are OTC Hearing Aids NOT appropriate for? �

​

​

​

​

​

​

​

​

​

​

​

1. Congenital or traumatic deformity of the ears
2. Active drainage from the ear within the previous 90 days
3. Significant cerumen (wax) accumulation or a foreign body in the ear canal
4. Pain or discomfort in the ear
5. Acute or chronic dizziness
6. Audiometric air-bone gap equal to or greater than 15 dB at 500, 1000, and 2000 Hz
7. Sudden or rapidly progressive hearing loss within the previous 90 days
8. Unilateral hearing loss of sudden or recent onset within the previous 90 days

What is the Difference between a Prescribed Hearing Aid and an OTC Hearing Aid?

PRESCRIPTION HEARING AID

• Audiometric testing used to prescribe hearing aids

​

​

​

​

OVER THE COUNTER HEARING AID

• No testing required

​

• Initial dispensing of the instruments, Follow up Care, routine maintenance, and repairs are typically performed by the provider during the warranty of the hearing aid
• Service models vary greatly amongst offices

​

​

​

​

• Designed for all ages and degrees of hearing loss

​

​

​

​

​

• Designed for “Perceived Mild to Moderate” hearing losses
• Only for ages 18 +

​

• No involvement of a licensed provider

​

The ONLY FDA Cleared OTC Device

Bose Sound Control Hearing Aids

$895 pair

• Online Hearing Screening
• Rechargeable
• No Bluetooth (yet?)

​

Are OTC Hearing Aids the Solution?

• Purpose of the OTC bill is to make hearing aids more affordable and accessible
• Currently only 20% of patients who COULD benefit from hearing aids actually wear them
• European Union
• Hearing aids for free to their citizens
• 55 million individuals with hearing loss
• Only 1 in every 6 wear amplification.

CASE STUDIES:�What determines patient success with amplification?

TYPE OF INSTRUMENT, PROVIDER, BOTH?

Why do patients fail with hearing aids?

• 1) Patient does not acknowledge hearing difficulty/not motivated to use hearing aids
• 2) Patient waited too long to treat hearing loss
• Reduced word understanding and auditory processing from auditory deprivation
• 3) Hearing device not appropriate for hearing loss
• 4) Hearing device not appropriately prescribed
• Too much access to sound too soon
• Verification not used

5) Inadequate orientation and/or follow up care

Why do patients fail with hearing aids?

• 1) Patient does not acknowledge hearing difficulty and is not motivated to use hearing aids

​

• Hearing Aids have to be WORN to be effective

​

​

​

Why do patients fail with hearing aids?

Spouse or loved ones cannot be motivated enough for the patient

​

​

​

"When someone in the family has a hearing loss,

the entire family has a hearing problem.”

– Mark Ross Ph.D.

Why do patients fail with hearing aids?

• 2) Patient waited too long to treat hearing loss
• Reduced word understanding and auditory processing from auditory deprivation

​

• X and O show us how loud we need to make sound before the EAR can detect it and send a signal to the brain
• Word Recognition Score tells us how well the brain can turn sound into words in IDEAL circumstances

​

100%

76%

Soft

Loud

Bass

Treble

Why do patients fail with hearing aids?

Soft

We Hear With Our BRAIN

• The EAR detects sound
• Our BRAIN turns sound back

into meaningful language

Why do patients fail with hearing aids?

• 3) Hearing device not appropriate for hearing loss

Why do patients fail with hearing aids?

• 3) Hearing Device not appropriately prescribed

Too much access to sound too soon

Verification NOT performed

Why do patients fail with hearing aids?

• 4) Inadequate counseling and/or follow up care
• Cleaning and Maintenance
• Firmware updates
• Annual hearing tests

How Hearing Aids are Prescribed

• When hearing results are used to generate a prescription, our software assumes that the patient has the exact average size ear canal (2cc).

KEMAR

But the Human Ear is �as Unique as a Fingerprint!

• Sound changes based on the space in which it occurs
• If someone has a larger than average ear canal we are likely UNDER amplifying them
• If someone has a smaller than average ear canal we are likely OVER amplifying them!

What is Real Ear Verification

• Real-ear verification takes into account an individual's unique anatomy, such as ear canal volume, providing a true measurement of a hearing aid's effectiveness for that patient's specific hearing loss.

Soft

Loud

Bass

Treble

Where they begin hearing

White Shaded Area is the prescriptive target

The goal is to get the squiggly lines in the white shaded area

DISCLAIMER

• This is in no way a review of any specific product or delivery method.
• The questions is, if a device is being dispensed, why is it being dispensed?
• How do we know that it is actually doing what we want it to and helping the patient?

Case Study 1

• 41 YEAR OLD PATIENT

• Resound Hearing Aids Dispensed From a local Costco
• Felt that his hearing aids didn’t help him hear conversation any better and only amplified environmental noise
• 15 years of known hearing loss with inconsistent use of hearing aids reported

​

​

​

Original Programming

After Re-Programming

Case Study 2

• 92 YEAR OLD PATIENT

• Recently purchased top of the Line Phonak Hearing aids with a provider out of state
• Long Term hearing aid user, but feels her new hearing aids were too shrill and “tinny”

​

​

​

​

After Re-Programming

Original Programming

Case Study 3

• 88 YEAR OLD PATIENT

• History of dementia and has lost 1 set of hearing aids already
• Son purchased Olive Pro Devices for $299 and can easily see if his father is wearing them

​

​

​

App

Adjustments

Default

Settings

Which guitar do you think sounds better?

1956 GIBSON HUMMINGBIRD

$10,900

ROGUE RA-090

$69.99

Which guitar do you think sounds better?

1956 GIBSON HUMMINGBIRD

$10,900

ROGUE RA-090

$69.99

Abel

(My Nephew)

Eric Clapton

EXACTLY!

• We know that the quality of the sound we hear is more dependent on the musician than the guitar!
• This is the way that I feel about Hearing Aids… Prescribed and OTC alike
• The quality of the hearing aid fitting is more influenced by the standard of care and verification used by the provider than the device itself
• Both Musical Instruments and Hearing Instruments are going to sound best when in the hands of an experienced professional!

The Take Away: What is the Ultimate Goal?

• The end goal is to improve hearing.
• Any device, regardless of technology level, is going to function best in the hands of a professional following Best Practice Standards.
• OTC Hearing aids as “Training Wheels”

“Training Wheels for Hearing Aids”

• If the end goal is to improve hearing….
• Earlier treatment of hearing loss
• Retain auditory processing
• Sensorineural hearing loss
• Permanent
• Progressive
• More successful hearing aid users when prescribed devices become necessary

Change on the Horizon?

• Medicare Insurance coverage for hearing aids?

​

Change on the Horizon?

• SOME Private insurances do currently offer “benefits”
• Perform your due diligence
• Not all insurance plans are created equal
• Actual Benefit vs Discount Plan
• Third Party Payers
• Access to follow up care?

​

Questions?