Cochlear Implant, Hearing Aid, Sensorineural Hearing Loss
Conditions
Brief summary
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
Interventions
DEVICEAnatomy-based fitting
Programming of cochlear implant speech processor with anatomy-based fitting
DEVICEDefault fitting
Programming of cochlear implant speech processor according to standard clinical care
Sponsors
Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Subject implanted with MED-EL cochlear implant(s) * Subject received a Flex28, FlexSoft or Standard electrode * Subject uses a SONNET 2 or RONDO 3 audio processor * Subject has experience of at least 6 months with cochlear implant * The most apical active electrode contact has to be inserted at least 540° * Minimum of 10 active channels are activated * Subject wears an adequately fitted hearing aid on the contralateral side * 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech recognition test in quiet | Day 1 (single study visit), post intervention | Percentage correctly identified phonemes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech recognition test in noise (S0N0, S0N90) | Day 1 (single study visit), post- intervention | Speech reception threshold in dB SNR |
| Vowel and consonant identification task (ASSE) | Day 1 (single study visit), post-intervention | Number of correctly identified vowels and correctly identified consonants |
| Pitch and timbre ranking | Day 1 (single study visit), post intervention | Score on visual analog scale (VAS) with a range from 0 (duller than the reference) to 10 (brighter than the reference). The score of 5 means an exact match with the timbre or pitch of the hearing aid. |
Countries
Belgium
Outcome results
None listed