Anatomy-based fitting for cochlear implant users
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
NA · Universitair Ziekenhuis Brussel · NCT05451628
This study tests a new way to fit cochlear implants using CT scans of the ear to see if it helps people with severe hearing loss hear better compared to the usual fitting method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 1 site (Brussel) |
| Trial ID | NCT05451628 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new fitting strategy for cochlear implants (CIs) that uses post-operative CT scans to create a personalized frequency-band distribution for sound perception. Currently, most CI recipients are fitted using a default map that does not consider individual cochlear anatomy. By aligning the fitting more closely with the natural frequency distribution of a normal hearing cochlea, the study aims to improve auditory outcomes for patients with severe to profound hearing loss. Participants will be randomly assigned to receive either the standard fitting or the new anatomy-based fitting approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with post-lingual severe to profound sensorineural hearing loss who are receiving a MED-EL cochlear implant.
Not a fit: Patients who are using Electric Acoustic Stimulation (EAS) or do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved sound perception and overall hearing outcomes for cochlear implant users.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method in cochlear implant fitting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Lack of compliance with any inclusion criteria * Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor) * Implanted with C40+, C40X and C40C * Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array * Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
Where this trial is running
Brussel
- UZ Brussel — Brussel, Belgium (RECRUITING)
Study contacts
- Principal investigator: Vedat Topsakal, Prof. — UZB-VUB
- Study coordinator: Emilie Heuninck
- Email: emilie.heuninck@uzbrussel.be
- Phone: +3224749772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cochlear Implants, Sensorineural Hearing Loss