Sensorineural hearing loss, cochlear implants Hearing loss
Conditions
Interventions
CE-marked devices used within clinical indication:CI: MED-EL Flex series implant + MED-EL processors (Sonnet/Rondo).Software: MAESTRO fitting software
OTOPLAN anatomy analysis and planning software.Interventions:ABS: imaging-based electrode array length selection.ABF: imaging-based personalized FAT derived from measured electrode position, compared
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (18y or older) and meeting the conventional Dutch CI criteria;Proficient speaker of Dutch language;Post-lingual onset of profound deafness (> 4 years of age);Subject receives a MED-EL cochlear implant from their Flex collection and a MED-EL sound processor (Sonnet/Rondo)Rehabilitation at CI ZON for the first year after surgery regarding CI as well as HA;Active participation in trial related procedures such as daily randomization and regular testing.
Exclusion criteria
Exclusion criteria: Physical or non-physical contraindications for MRI or CT imaging;Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;Active participation in another prospective clinical trial;Pregnancy or pregnancy wish at time of inclusion;Having received a cochlear implant earlier in the same ear (e.g. explantation);EAS (electro-acoustic stimulation) candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ABS primary endpointsAngular insertion depth (AID) derived from post-operative PC-CT (and reassessed at 6 months).Number of deactivated electrodes recorded at each fitting session.ABF primary endpointsSubjective preference / satisfaction for ABF vs standard FAT, assessed repeatedly using a VAS.Speech understanding in quiet: Dutch CNC word recognition score measured at each visit for each program. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include (timing per protocol):Speech perception: sentences in quiet and in noise; Dutch Matrix sentence test (incl. SRT in noise) at key timepoints.Patient-reported outcomes / QoL: SSQ (short form), NCIQ, and a sound quality questionnaire (Dutch descriptors).Bimodal outcomes (where contralateral HA is used).Extended auditory perceptual dimensions: listening effort (ACALES), spectral resolution (Quick SMRT), loudness scaling (ACALOS), sound quality.Music perception: UCSF Music quality test; consonance-dissonance ranking. Learning curve endpoints: repeated CNC in quiet across visits for ABF vs standard; additional acute alternative fitting strategies tested at weeks 0, 2, 4, 6, 8, 12, and 24 (and word-in-noise at weeks 8 and 24). | — |
Countries
Netherlands
Contacts
Public ContactD. D. Junggeburt
Maastricht Universitair Medisch Centrum +
Outcome results
None listed