Investigations of Ear Tip Performance, Perceptions, and Experiences

University of Arizona30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Aids

Interventions

BTE hearing aid with compatible earmoldsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: Prior to 2nd listening session appointment (15 minutes)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.