Cochlear Implants, Sensorineural Hearing Loss
Conditions
Brief 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.
Interventions
DEVICEDefault CI fitting
Programming of cochlear implant speech processor according to standard clinical care
DEVICEAnatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Sponsors
Universitair Ziekenhuis Brussel
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 * 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, SONNET 3 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Speech recognition test in quiet (S0): percentage correctly identified phonemes | 3 months post-activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR | 3 months post-activation | — |
| Result of the pitch matching test: frequency difference in semitones | 3 months post-activation | — |
| Result of the pitch matching test: frequency differences in semitones | 6 months post-activation | — |
| Result of the perception of timbre test: Score on Visual Analog Scale (VAS) | 3 months post-activation | Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome. |
| Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure | 3 months post-activation | — |
| Result of the speech contrast discrimination test: Psychometric function of phoneme categorization | 3 months post-activation | — |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | 1 day visit (At the activation of the sound processor) | — |
| Datalogging data: Average numbers of hours per day | 2 weeks post-activation | — |
Countries
Belgium
Outcome results
None listed