ATLAS Over-the-Counter (OTC)
Hearing Aid
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OTC Self-Check & Monitor Tool
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OTC Assistant App
for improved audibility
The October 2021 FDA Proposed Rule establishes OTC hearing aids to improve access to millions
37.5 M American adults report hearing troubles
Only 20% use hearing aids
Due to cost, purchase restrictions, social stigma, perceived poor performance of hearing aids
OTC Hearing Aids address these issues
User decision
Self-diagnose condition
No prescription,
no involvement of licensed professionals
User control
Select settings per listening needs
Know when to seek medical consult
Hearing aid quality
Effectiveness, safety, design per national standards
Use, care and maintenance support
Ease of purchase
No state/federal restrictions,
no appointment fees
Lower cost due direct sale to user
Reference: FDA OTC Draft Rule
ATLAS OTC Hearing Aid
Provides sound amplification for those who are at least 18 years old and have self-identified mild to moderate hearing loss.
The Hearing aid can be obtained online without a prescription and without the involvement of a licensed professional.
OTC Self-Check & Monitor Tool
For self-evaluation and decision-making:
self-diagnose mild to moderate hearing loss
make decisions for hearing-aid purchase
know signs for immediate medical consult
understand other symptoms
be aware of unmodifiable and modifiable risks
select practical options for protection & prevention
self-monitor whenever desired
prepare for medical appointments
OTC Assistant App
For Hearing Aid use improvement:
clear directions for use and user support line
timely access to supplies and maintenance
tracking safety of sound exposures
wear time reports and suggestions
music enjoyment suggestions
telephone conversation support
The App functions do not control or impact functioning of the OTC hearing aid.
Products in development and discussed with FDA at Pre-Submission meetings. Will conform to FDA Final OTC Rule.