Anatomy-based fitting for single-sided deaf CI users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with single-sided deafness who have recently received a cochlear implant will have either anatomy-based fitting or default fitting. The study will measure speech perception in noise across different spatial setups, music perception using objective tests and the Music and Cochlear Implant Questionnaire, and localization plus self-reported hearing benefit. Outcomes include HISQUI19 and SSQ12 scores to capture user experience. All participants will have MED-EL implants and be assessed post-operatively with CT data and specific electrode configurations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Post-lingual onset of unilateral severe-to-profound sensorineural hearing loss
* Contralateral hearing \< 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
* Post-operative Computed Tomography (CT) scan of the CI elec-trode available
* Subject implanted with MED-EL cochlear implant(s)
* Subjects received a Flex20, Flex24, Flex28, FlexSoft, Flex34 or Standard electrode
* Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
* Newly implanted CI users
* The most apical active electrode contact has to be inserted at least 540°
* 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
* Implanted with C40+, C40X and C40C
* Implanted with an ABI or Split electrode array
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Where it's running

• Antwerp University Hopsital
  Antwerp, Belgium Recruiting

Study contacts

• Principal investigator: Griet Mertens, Prof. — University Hospital, Antwerp

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.