Investigations of Ear Tip Performance, Perceptions, and Experiences

Not Applicable

Completed

Conditions: Hearing Aids

Registration Number: NCT05725824

Lead Sponsor: University of Arizona

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Production Variable	Prior to 2nd listening session appointment (15 minutes)	The total raw cost ($) for each ear mold type (3rd party_control, in-house_RES, and in-house_PLA).
Real Ear Measures	15 minutes	Evaluation of ear canal acoustics with participant wearing a hearing aid and earmold type (3d party control, in-house_Resin, in-house_PLA). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the earmold type is changed and recording is repeated until all ear mold material types have been tested for each individual. Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.
Physical Dimensions	Prior to 2nd listening session appointment (15 minutes)	Physical dimensions of each ear mold type (3rd party Control, in-house_Resin, in-house_PLA) were taken using digital calipers in millimeters prior to being worn by participants.
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire	2nd listening session appointment (15 minutes)	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