3D Printing, Hearing Aids, Hearing Loss, Bilateral Sensorineural
Conditions
Keywords
hearing aids, 3D printing, hearing loss
Brief summary
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.
Interventions
DEVICEBTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)
Hearing 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.
DEVICEBTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)
Hearing 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
DEVICEBTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)
Hearing 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
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outer EAR comfort questionnaire | through study completion, an average of 1 week | 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. |
| Real Ear Measures | through study completion, an average of 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | through study completion, an average of week | The total raw cost ($, dollars US) |
| Time | through study completion, an average of week | Time-to-subject for each ear tip type |
Countries
United States
Contacts
CONTACTBryan Wong, AuD, PhD
Outcome results
None listed