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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABF fitting followed by standard fitting | Active Comparator |
| |
| Standard fitting followed by ABF fitting | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-operative ABF followed by fitting according to clinical standard | Device | Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR | 3 months post- activation | |
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR | 6 months post- activation | |
| Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR | 8 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Speech recognition in quiet: Percentage correctly identified phonemes | 3 months post-activation | |
| Speech recognition in quiet: Percentage correctly identified phonemes | 6 months post-activation | |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of electrode contact location: Degrees of deviation | 8th months post activation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Heuninck | Contact | 024749772 | emilie.heuninck@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Vedat Topsakal, Prof. | UZB-VUB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Recruiting | Brussels | 1090 | Belgium |
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| Fitting according to clinical standard followed by post-operative ABF | Device | Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months. |
|
| Speech recognition in quiet: Percentage correctly identified phonemes |
| 8 months post-activation |
| Speech discrimination: Number of correctly discriminated pairs of phonemes | 3 months post- activation |
| Speech discrimination: Number of correctly discriminated pairs of phonemes | 6 months post- activation |
| Speech discrimination: Number of correctly discriminated pairs of phonemes | 8 months post- activation |
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) | 1 month post- activation |
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) | 3 month post- activation |
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) | 6 months post- activation |
| Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL) | 8 months post- activation |
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | 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. | Baseline at activation |
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | 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. | 3 months post- activation |
| Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | 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. | 6 months post- activation |
| Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain | 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. | 8 months post- activation |
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): 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 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. | Baseline at activation |
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): 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 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. | 3 months post- activation |
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): 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 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. | 6 months post- activation |
| Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): 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 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. | 8 months post- activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): 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. | Baseline at activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): 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. | 3 months post- activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): 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. | 6 months post- activation |
| Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): 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. | 8 months post- activation |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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