Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)

• Post-operative Computed Tomography (CT) scan of the CI electrode available

• Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available

• Subject implanted with MED-EL cochlear implant(s)

• Subjects received a Flex28, FlexSoft or Standard electrode

• Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side

• Audio processor not yet activated on the newly implanted side

• The most apical active electrode contact has to be inserted at least 450°

• Minimum of 10 active channels can be activated

• Fluent in the language of the test centre

• Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Locations
Other Locations
Belgium
UZ Brussel
RECRUITING
Brussels
Contact Information
Primary
Emilie Heuninck
emilie.heuninck@uzbrussel.be
+3224749772
Time Frame
Start Date: 2022-03-30
Estimated Completion Date: 2025-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Default CI fitting
Programming of cochlear implant speech processor according to standard clinical care
Active_comparator: Anatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Related Therapeutic Areas
Sponsors
Leads: Universitair Ziekenhuis Brussel

This content was sourced from clinicaltrials.gov