Investigations of Ear Tip Performance, Perceptions, and Experiences

Hearing Aids Clinical Trial

— IETPPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725824
• Other study ID #: STUDY00002336
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2023
• Source: University of Arizona
• Contact: Bryan M Wong, AuD
• Phone: (520) 621-1644
• Email: bryanwong[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.

• Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.

• English as primary spoken language.

Exclusion Criteria:

• history of extensive or current outer or middle ear pathology.

• history of extensive outer or middle ear surgery.

• history of neurological or cognitive disorder.

Related Conditions & MeSH terms

• Hearing Aids

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real Ear Measures	Evaluation of ear canal acoustics with participant wearing hearing aid and earmold. A thin microphone tube is placed in the ear canal to measure the average amount of sound across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples.	2nd listening session appointment (~2.5 hours)
Primary	Outer Effectiveness of Auditory Rehabilitation (EAR) questionnaire	A questionnaire eliciting patient perception of physical comfort, quality of voice, and overall self-perceived satisfaction. Includes 12 items (5 point) that are scored on a 0 to 100, with 100 representing best possible function/rating	2nd listening session appointment (~2.5 hours)
Primary	Speech Spatial Qualities (SSQ) questionnaire:	A subsection of this questionnaire, " qualities of hearing", will be administered to evaluate participant's perceptions of acoustic quality and comfort. This subsection includes 18 items (10 points) that are scored on a 0 to 10, with 10 representing best possible function/rating	2nd listening session appointment (~2.5 hours)
Secondary	Physical variables	Physical dimensions of earmolds will be taken using digital calipers. Does not require participants to be present.	Prior to 2nd listening session appointment (~7-14 days)
Secondary	Production variables	The total raw cost ($) and time (min) of production will be measured for each earmold group.	Prior to 2nd listening session appointment (~7-14 days)