Hearing Loss, Sensorineural
Conditions
Keywords
cochlear implant, sound processor
Brief summary
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
Detailed description
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.
Interventions
DEVICECI532
Cochlear implant
DEVICENucleus 7
Sound processor
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss. 2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level. 3. Bilateral moderate sloping to profound hearing loss 4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method 5. Proficient in English 6. Ability to complete testing -
Exclusion criteria
1. Previous cochlear implantation 2. Pre-linguistically deafened (onset of hearing loss at less than two years of age) 3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array 4. Duration of severe to profound hearing loss greater than 20 years 5. Diagnosis of retro-cochlear pathology 6. Diagnosis of auditory neuropathy 7. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device 8. Unwillingness or inability to comply with all investigational requirements 9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone | Preoperatively and 6 months post sound processor activation | Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone | Preoperatively and 6 months post sound processor activation | Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores. |
| Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3) | Preoperatively and 6 months post sound processor activaton | Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency Specific Thresholds and Speech Recognition in Noise or Quiet | 12 months post-activation | Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone. |
| Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming | Following 12-month study visit but prior to 36-month interval. | Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CI532/N7 Study Group All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
CI532: Cochlear implant
Nucleus 7: Sound processor | 96 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Did not have aidable contralateral thresholds at the time | 2 |
| Overall Study | Loss to Follow Up | 1 |
Baseline characteristics
| Characteristic | CI532/N7 Study Group | — |
|---|---|---|
| Age, Continuous | 67.39 years | — |
| Contralateral Ear Mean - Duration of Hearing Loss | 26.7 years STANDARD_DEVIATION 14 | — |
| Ipsilateral Ear Mean - Duration of Hearing Loss | 21.7 years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 96 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 62 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 96 |
| other Total, other adverse events | 26 / 96 |
| serious Total, serious adverse events | 16 / 96 |
Outcome results
Primary
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Time frame: Preoperatively and 6 months post sound processor activation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI532/N7 Study Group | Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone | Baseline Ipsilateral Aided | 14.6 percentage of correct words | Standard Deviation 11.6 |
| CI532/N7 Study Group | Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone | 6 Month CI/Best Unilateral | 60.9 percentage of correct words | Standard Deviation 21.09 |
Secondary
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).
Time frame: Preoperatively and 6 months post sound processor activaton
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI532/N7 Study Group | Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3) | Baseline | 0.46 score on a scale | Standard Deviation 0.2 |
| CI532/N7 Study Group | Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3) | 6 Month | 0.64 score on a scale | Standard Deviation 0.197 |
Secondary
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.
Time frame: Preoperatively and 6 months post sound processor activation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CI532/N7 Study Group | Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone | Baseline Ipsilateral Aided +10 SNR | 14.8 percentage of correct AzBio sentences | Standard Deviation 17.24 |
| CI532/N7 Study Group | Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone | 6 Month CI/Best Unilateral +10 SNR | 42.7 percentage of correct AzBio sentences | Standard Deviation 26.21 |
Other Pre-specified
Frequency Specific Thresholds and Speech Recognition in Noise or Quiet
Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.
Time frame: 12 months post-activation
Other Pre-specified
Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming
Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.
Time frame: Following 12-month study visit but prior to 36-month interval.