Investigations of Ear Tip Performance, Perceptions, and Experiences (IETPPE)

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Aids
• Intervention / Treatment: Device: BTE hearing aid with compatible earmolds

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Third-party control; 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; 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.
Experimental: In-house Study group_Resin; 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; 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.
Experimental: In-house Study group_PLA; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: hearing aid; earmold
• Other Study ID Numbers: STUDY00002336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes