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

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

Profile

-your risk factors and hearing healthcare needs  ​

-factors that are modifiable or non-modifiable

Identify

-your mild to moderate hearing difficulties

-other serious hearing and ear related conditions

Select

-the treatment option based on your condition

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

Monitor

-your Hearing Health 

-your Quality of Life

Journal

-your notes to discus 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

REFERENCES: 

* FDA description of OTC medical device characteristics

**FDA defines 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