Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Arizona
About this trial
Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss
Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
English speaking.
Disqualifiers
Self reported history of extensive or current outer or middle ear pathology.
Self reported history of extensive outer or middle ear surgery.
Self reported history of neurological or cognitive disorder.
Active ear infection
Trial design
Design model
Crossover
Treatments tested in this trial
BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)
DeviceHearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group.
BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)
DeviceHearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group
BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)
DeviceHearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group
Treatment groups
32 Participants
are divided into 3 treatment groupsGroup A: In-house Study group_ResinExperimental treatment 1 intervention
Group B: Third-party ManufacturedActive comparator 1 intervention
Group C: In-house Study group_FlexibleResinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Outer EAR comfort questionnaire
A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function/rating.
Time frame
through study completion, an average of 1 week2
Real Ear Measures
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house\_Resin, in-house\_FlexResin). 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.
Time frame
through study completion, an average of 1 weekSecondary outcomes
1
Cost
The total raw cost ($, dollars US)
Time frame
through study completion, an average of week2
Time
Time-to-subject for each ear tip type
Time frame
through study completion, an average of weekSponsors and contacts
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Source ClinicalTrials.gov