Cochlear Implant, Sensorineural Hearing Loss, Single Sided Deafness
Conditions
Brief summary
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
Interventions
DEVICEAnatomy-based fitting
Anatomy-based programming of the speech processor of the cochlear implant
DEVICEDefault fitting
Default programming of the speech processor of the cochlear implant according to standard clinical practice
Sponsors
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech perception in noise | 3 months post-activation of the audioprocessor | Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pitch ranking | 3 months post-activation | Frequency difference in semitones between CI and NH |
| Perception of timbre | 3 months post-activation | Score on Visual Analog Scale (VAS). Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH. |
| Localization | 3 months post-activation | Root mean square localization error (RMSE) in degrees |
| Melodic interval perception | 3 months post-activation | Psychometric function of melodic intervals |
| Sound quality | 3 months post-activation | Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D) |
| HISQUI19 questionnaire | 3 months post-activation | Total score and classification of self-perceived auditory benefit. The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit. |
| Speech, Spatial and Qualities of Hearing scale (SSQ12) | 3 months post-activation | Total score and score in the speech, spatial and quality domain. The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items. For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome. |
| Music and cochlear implant questionnaire (MCIQ) | 3 months post-activation | Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORGriet Mertens, Prof.
University Hospital, Antwerp
Outcome results
None listed