American research 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 prolonged duration in people with bilateral hearing loss.
The study will also compare how long each method takes to make and how much each costs.
Behind-the-ear (BTE) hearing aids with compatible ear tips will be used.
Ear tips are small, interchangeable nozzle covers for in-ear hearing aids or earbuds that fit into the ear canal.
Audiologist Dr Bryan Wong from The University of Arizona Hearing Clinic will conduct the randomised trial on adults with bilateral, symmetric, sensorineural hearing loss, and thresholds between normal and severe hearing loss.
Patients must have normal otoscopy – patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
He said hearing aids would be fitted with three different types of customised ear tips including resin ear tips, and participants would wear each ear tip for one week including resin.
They will answer a validated questionnaire, Outer EAR, to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction.
Real Ear Measures (REMs) will include evaluation of ear canal acoustics with participants wearing a hearing aid and ear tip type.
A thin microphone tube will be 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 will be recorded in gain (dB SPL) across frequencies.
The study details were reported on the US website ClinicalTrials.gov.
