Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Presentation Icons

Tier 1

Ethics

HearTECH Hub

Ticket Required

Back

Amplification and Assistive Devices (AAD)

Clinically Standard Verification and Validation of OTC Self-Fitting Hearing Aids

PP302 - Clinically Standard Verification and Validation of Over-the-Counter Self-Fitting Hearing Aids

POSTERS

Location: Halls A1-A2

Instructional Level: Intermediate

Lead Presenter(s)

Lauren Pasquesi, AuD (she/her/hers)

Eargo, Inc.

Disclosure(s): Eargo, Inc.: Employment (Ongoing)

PDF Handouts Slides

Contributor(s)

JR

Joyce Rosenthal

Eargo

Disclosure(s): Eargo, Inc.: Employment (Ongoing)
Tong Sheng, PhD (he/him/his)

Clinical Science Senior Manager
Eargo, Inc.
San Jose, California

Disclosure(s): Eargo, Inc.: Employment (Ongoing)
Andrew J. Johnson (he/him/his)

Eargo

Disclosure(s): Eargo, Inc.: Employment (Ongoing)
TA

Travis Allyn

Eargo, Inc.

Disclosure(s): No financial or nonfinancial relationships to disclose.
JS

Jayaganesh Swaminathan, PhD (he/him/his)

Director - Acoustics & Clinical Science
Eargo, California

Disclosure(s): No financial or nonfinancial relationships to disclose.

Abstract:
In 2022, the US Food and Drug Administration issued final regulations to establish a category of over-the-counter (OTC) hearing aids. As these regulations are new and technology is rapidly changing, users’ objective and subjective outcomes with these devices are yet to be well understood. In this study, in-development self-fitting hearing aids were provided to users, then self-fitting results were separately verified and validated using standard clinical procedures. The purpose of this study was to evaluate the objective fitting of an OTC self-fitting device as well as the subjective effectiveness and satisfaction with in-field device use

Summary:
Rationale/

Purpose:
OTC self-fitting hearing aids are still considered to be nascent technology. As such, questions relating to clinical efficacy and user satisfaction of this approach still remain. The purpose of this study was to evaluate the objective fitting of an OTC self-fitting device as well as the subjective effectiveness and satisfaction with in-field device use. We hypothesize that the self-fitting OTC hearing aids can perform similarly to expected clinical outcomes using traditional verification and validation measures.

Methods:
24 subjects were recruited for this study and were fit with Eargo OTC self-fitting hearing aids. Subjects followed self-fitting procedures provided by the manufacturer’s in-app instructions. A traditional audiogram was completed in a test booth by an experienced audiologist, who was blinded to the results of the subject’s self-fitting test results. The results of the booth audiogram and app audiogram were compared. The output of the self-fit devices was verified with the Audioscan Verifit 2 using NAL-NL2 targets based on the subject’s hearing thresholds obtained from the gold standard booth measurements. Real-world sound quality and overall hearing-aid satisfaction were validated with APHAB and COSI questionnaires after 4-5 weeks of device wear in-field.

Results &

Conclusions:
As the study is currently ongoing, the results and conclusions are not yet available. The study is expected to be completed in December 2023.
Learning Objectives:
Analyze subjective and objective outcomes of OTC self-fitting hearing aids