NCT05725824

Investigations of Ear Tip Performance, Perceptions, and Experiences

Novel Technology Adoption in the Audiology Clinic: Investigations of Ear Tip Performance, Perceptions, and Experiences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-07-30
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2023-02-13
• Last updated: 2024-07-29
• Results posted: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study