Sensorineural Hearing Loss
Conditions
Keywords
High frequency severe to profound
Brief summary
The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.
Interventions
DEVICENucleus Hybrid L24
Implantation with Nucleus Hybrid L24 cochlear implant
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eighteen years of age or older at the time of implantation. 2. Severe to profound (a threshold average of 2000, 3000, & 4000 Hz \> 75dB HL) sensorineural hearing loss for frequencies \> 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL. 3. Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% \<= score \<= 60%), in the ear to be implanted. 4. CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%. 5. English spoken as a primary language.
Exclusion criteria
1. Duration of severe-to-profound hearing loss greater than 30 years. 2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). 3. Medical or psychological conditions that contraindicate undergoing surgery. 4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. 5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz. 6. Hearing loss of neural or central origin. 7. Diagnosis of Auditory Neuropathy. 8. Active middle-ear infection. 9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices. 10. Unwillingness or inability of the candidate to comply with all investigational requirements. 11. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) | 6 Months Postactivation | The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study. |
| AzBio Sentence Score in Noise - Treated Ear (Co-Primary) | 6 Months Postactivation | The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear | 6 Months Postactivation | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported. |
| AzBio Sentence Score-Treated Ear | 6 Months Postactivation | Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgery Implantation with the Nucleus Hybrid L24 Cochlear Implant | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Surgery |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 14.7 |
| AzBio sentences | 16.3 percent correct STANDARD_DEVIATION 14.4 |
| Duration of hearing loss | 28.1 years STANDARD_DEVIATION 14.9 |
| Duration of severe to profound high frequency hearing loss | 13.1 years STANDARD_DEVIATION 7.2 |
| Monosyllabic words | 28.4 percent correct STANDARD_DEVIATION 14.7 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)
The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score.
Time frame: 6 Months Postactivation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Months Postactivation | AzBio Sentence Score in Noise - Treated Ear (Co-Primary) | 49.2 percentage of words correct | Standard Deviation 30.8 |
Primary
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.
Time frame: 6 Months Postactivation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Months Postactivation | Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) | 65.4 percentage of words correct | Standard Deviation 25.4 |
Secondary
AzBio Sentence Score-Treated Ear
Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported.
Time frame: 6 Months Postactivation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Months Postactivation | AzBio Sentence Score-Treated Ear | 89.9 percentage of subjects |
Secondary
Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear
Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported.
Time frame: 6 Months Postactivation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Months Postactivation | Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear | 96 percentage of subjects |