Investigations of Ear Tip Performance, Perceptions, and Experiences

NCT05725824 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00002336
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Aids

Keywords

earmold; hearing aid

Outcome Measures

Primary Outcomes (4)

• Real Ear Measures

  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.

  15 minutes

• 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 (15 minutes)

• Physical Dimensions

  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.

  Prior to 2nd listening session appointment (15 minutes)

• Production Variable

  The total raw cost ($) for each ear mold type (3rd party\_control, in-house\_RES, and in-house\_PLA).

  Prior to 2nd listening session appointment (15 minutes)

Study Arms (3)

Third-party control

ACTIVE COMPARATOR

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).

Device: BTE hearing aid with compatible earmolds

In-house Study group_Resin

EXPERIMENTAL

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).

Device: BTE hearing aid with compatible earmolds

In-house Study group_PLA

EXPERIMENTAL

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).

Device: BTE hearing aid with compatible earmolds

Interventions

BTE hearing aid with compatible earmolds DEVICE

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.

In-house Study group_PLA; In-house Study group_Resin; Third-party control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• history of extensive or current outer or middle ear pathology.
• history of extensive outer or middle ear surgery.
• history of neurological or cognitive disorder.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Results Point of Contact

• Title: Dr. Bryan Wong
• Organization: University of Arizona

bryanwong@arizona.edu

5206268549

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: July 30, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)