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OpenTrials
Completed

NCT Number: NCT05725824

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.

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Key information

Conditions

Hearing Aids

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Real Ear Measures

    Time frame: 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.

  2. Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire

    Time frame: 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

  3. Physical Dimensions

    Time frame: 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.

  4. Production Variable

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: IETPPE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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