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Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
NCT05369598 · Universitair Ziekenhuis Brussel · Updated 12 Dec 2023
- What is being tested
- Post-operative ABF followed by fitting according to clinical standard; Fitting according to clinical standard followed by post-operative ABF
- For
- Cochlear Implants; Sensorineural Hearing Loss, Bilateral
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 30 people. The full rules are on the registry page.
- Where
- Belgium
- When
- Starts or started 1 March 2022, ends Feb 2025. Registered 11 May 2022.
- Results
- None posted yet.
In the researchers' words
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.
Sites
- UZ BrusselBrussels, Belgium