Hearing Loss
Conditions
Brief summary
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.
Detailed description
Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (HINT) in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.
Interventions
DEVICEcochlear implant
Cochlear implant surgery
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
Yes
Inclusion criteria
* Eighteen years of age or older at the time of the study. * Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear * Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above) * Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation. * English spoken as the primary language.
Exclusion criteria
* Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). * Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted * Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array. * Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway). * Active middle-ear infection. * Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNC Monosyllabic Word Score - Treated Ear | Six months | The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Implanted |
|---|---|
| Age, Continuous | 77 years |
| Preoperative AzBio Sentence Noise score - Treated Ear | 9.9 percent correct |
| Preoperative CNC word score - Treated Ear | 23.6 percent correct |
| Preoperative HINT Quiet score - Treated Ear | 62.3 percent correct |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
CNC Monosyllabic Word Score - Treated Ear
The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Time frame: Six months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Implanted | CNC Monosyllabic Word Score - Treated Ear | 57.1 percent correct |