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Hearing Aid

Earmold Performance for Hearing Aids (IETPPE Trial)

N/A
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to 2nd listening session appointment (~7-14 days)
Awards & highlights

IETPPE Trial Summary

This trial helps researchers understand how different earmolds affect hearing aids and how they can improve comfort and sound quality.

Who is the study for?
This trial is for people with normal hearing and ear health, who speak English as their primary language. They should have no history of neurological or cognitive disorders, extensive ear surgeries, or current severe ear problems.Check my eligibility
What is being tested?
Participants will try out a behind-the-ear (BTE) hearing aid paired with different custom earmolds. The aids are set to mimic mild hearing loss. Researchers will compare how these earmolds affect sound quality and comfort.See study design
What are the potential side effects?
Since this study involves standard BTE hearing aids and earmolds without medication or invasive procedures, significant side effects are not expected. Some participants might experience minor discomfort from the fit of the earmold.

IETPPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to 2nd listening session appointment (~7-14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to 2nd listening session appointment (~7-14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Outer Effectiveness of Auditory Rehabilitation (EAR) questionnaire
Real Ear Measures
Speech Spatial Qualities (SSQ) questionnaire
Secondary outcome measures
Physical variables
Production variables

IETPPE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: In-house Study group_ResinExperimental Treatment1 Intervention
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).
Group II: In-house Study group_PLAExperimental Treatment1 Intervention
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).
Group III: Third-party controlActive Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,564 Total Patients Enrolled

Media Library

BTE hearing aid with compatible earmolds (Hearing Aid) Clinical Trial Eligibility Overview. Trial Name: NCT05725824 — N/A
Hearing Aids Research Study Groups: In-house Study group_Resin, Third-party control, In-house Study group_PLA
Hearing Aids Clinical Trial 2023: BTE hearing aid with compatible earmolds Highlights & Side Effects. Trial Name: NCT05725824 — N/A
BTE hearing aid with compatible earmolds (Hearing Aid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05725824 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age bracket of seventy and over being considered for this clinical experiment?

"This research initiative is open to individuals who are of the age of majority or older and younger than eighty-nine years old."

Answered by AI

Is this research opportunity currently available to participants?

"The trial is not actively recruiting, as per information available on clinicaltrials.gov; the study was initially posted and last revised in March of 2023. Although this particular trial is not searching for patient participants at present, there are four other trials that currently require recruitment."

Answered by AI

Is there an opportunity for me to participate in this research study?

"This investigation is taking on a cohort of 30 people between 18 and 89 who are wearing hearing aids. Additional criteria necessitates normal auditory thresholds (<25 dB HL) from 250-8000 Hz, healthy ear canals with unencumbered eardrums and middle ears, as well as English being the primary language spoken."

Answered by AI

Who else is applying?

What site did they apply to?
University of Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Investigations of Ear Tip Performance, Perceptions, and Experiences
2023. "Investigations of Ear Tip Performance, Perceptions, and Experiences". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05725824.
~0 spots leftby May 2024
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