ATLAS Over-the-Counter (OTC)
Hearing Aid
+
OTC Self-Check & Monitor Tool 
+
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.