Cochlear Implants, Sensorineural Hearing Loss, Bilateral
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. This study will focus on patients that are already implanted with the HEARO robotic system.
Interventions
DEVICEPost-operative ABF followed by fitting according to clinical standard
Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.
DEVICEFitting according to clinical standard followed by post-operative ABF
Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.
Sponsors
Universitair Ziekenhuis Brussel
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) * Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS) * Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage * Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side * Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid) * Pre- operative and post-operative CT scan of the temporal bone available * Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available * Audio processor not yet activated on the newly implanted side * Minimum of 10 active channels can be activated * Fluent in the language of the test centre (Dutch or French) * Signed and dated ICF before the start of any study-specific procedure
Exclusion criteria
* Subject is a Single-Sided Deafness (SSD) CI user * Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor) * Lack of compliance with any inclusion criteria * 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 |
|---|---|
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR | 3 months post- activation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech recognition in quiet: Percentage correctly identified phonemes | 3 months post-activation | — |
| Speech discrimination: Number of correctly discriminated pairs of phonemes | 3 months post- activation | — |
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) | 1 month post- activation | — |
| Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | 8 months post- activation | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items. For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. |
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain | Baseline at activation | 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 on 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. |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit | Baseline at activation | 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. |
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | Baseline at activation | The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from Never to Always (Statement 1-55) or from No to Quite well (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome. |
Other
| Measure | Time frame |
|---|---|
| Evaluation of electrode contact location: Degrees of deviation | 8th months post activation |
Countries
Belgium
Contacts
Primary ContactEmilie Heuninck
Outcome results
None listed