NCT05369598

Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cochlear Implants
• Sensorineural Hearing Loss, Bilateral

Interventions

Type	Name	Description
DEVICE	Post-operative ABF followed by fitting according to clinical standard	Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.
DEVICE	Fitting according to clinical standard followed by post-operative ABF	Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2022-05-11
• Last updated: 2023-12-12

Locations

1 site across 1 country: Belgium