ATLAS Self-Analysis Tool 
for self-identification, self-selecting, 

Over-the-Counter (OTC) medical devices*, such as OTC Hearing Aids, are for sale directly to user who should be able to: 


ATLAS Self-Analysis Tool

is a self-administered questionnaire for at-home use for you to self-check, make clinical care decisions and manage your long-term Hearing Health and Quality of Life


-your risk factors and hearing healthcare needs  ​

-factors that are modifiable or non-modifiable


-your mild to moderate hearing difficulties

-other serious hearing and ear related conditions


-the treatment option based on your condition

-know when to select an OTC Hearing Aid and when to consult with a doctor


-your Hearing Health 

-your Quality of Life


-your notes to discuss with your doctor

-choose to share with others 

Tool features


A Patient Reported Outcomes (PRO) Tool*, in response to individually sequenced questions


Clinical care suggestions aligned with current practices

Self-monitoring reminders


Option to involve family member/caregiver 

 Tool is not a diagnostic


FDA description of OTC medical device characteristics

Federal Register Proposal for OTC Hearing Aid

FDA definition of PRO as any report of patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else