3D Printing, Hearing Aids
Conditions
Keywords
hearing aids, 3D printing, hearing healthcare accessibility
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. It will also compare how long each method takes to make and how much each costs.
Interventions
Hearing aids will be fit with three different types of customized ear tips. They will only wear each ear tip group for the duration of the test (total = 20 minutes). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 40 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear 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
Yes
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 speaking.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real Ear Measures | 2nd listening session appointment (15 minutes) | Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house\_Resin, in-house\_FlexResin). 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 eartip type is changed and recording is repeated until all eartip material types have been tested for each individual. |
| Outer EAR comfort questionnaire | 2nd listening session appointment (10 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | Prior to second listening session appointment (15 minutes) | The total raw cost ($, dollars US) |
| Time | Prior to second listening appointment (15 minutes) | time-to-subject for each eartip type |
Countries
United States
Contacts
CONTACTBryan Wong, AuD, PhD
Outcome results
None listed