Investigations of Ear Tip Performance, Perceptions, and Experiences

Not Applicable

Completed

• Conditions: Hearing Aids
• Interventions: Device: BTE hearing aid with compatible earmolds

• 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

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-13
• Study Start: 2023-07-30
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Results First Submitted: 2024-05-07
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Results First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
In-house Study group_PLA	BTE hearing aid with compatible earmolds	Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a fused deposition modeling 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
Third-party control	BTE hearing aid with compatible earmolds	Ear canal impressions will be will be packaged and sent to a professional third-party manufacturer for fabrication in an acrylic material-type. These will serve as the control earmolds, by which the in-house study/intervention earmolds will be compared against. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
In-house Study group_Resin	BTE hearing aid with compatible earmolds	Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a stereolithography 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing.To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).

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

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States