MedTrace Logo

Investigations of Ear Tip Performance, Perceptions, and Experiences

NCT05725824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-29

Study results available
· View outcomes & findings →

Summary

Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.

Conditions

  • Hearing Aids

Interventions

DEVICE

BTE hearing aid with compatible earmolds

Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \~2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2024-01-17
Completion
2024-01-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05725824 on ClinicalTrials.gov