Hearing Loss
Conditions
Brief summary
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant. The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
Interventions
DEVICECI532 cochlear implant
Sponsors
NYU Langone Health
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
* Meet current cochlear implant criteria at the implanting center * 18 years or older with bilateral sensorineural hearing loss * Limited benefit from appropriate binaural hearing aids * Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies * Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted * Fluent speaker in the language used to assess clinical performance
Exclusion criteria
* Evidence of hearing loss prior to age 5 * Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz * Simultaneous bilateral implantation prior to the study * Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery * Cochlear anomaly that might prevent complete insertion of the electrode array * Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway * Active middle ear infection * Tympanic membrane perforation * Unrealistic expectations * Unwillingness or inability co comply with all investigational requirements * Patients with existing cerebral shunts or drains * Recurrent episodes of bacterial meningitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AzBio Sentence Recognition in Noise | 3 months post-activation | The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 and the resulting score is presented in percent correct. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Benefit Inventory | 6 months post-activation | The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100. |
| Speech, Spatial, and Qualities of Hearing Scale | 6 months post-activation | The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgical Subjects implanted with the CI532 cochlear implant in one ear | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Surgical | — |
|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 0 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
AzBio Sentence Recognition in Noise
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests 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 and the resulting score is presented in percent correct.
Time frame: 3 months post-activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surgical | AzBio Sentence Recognition in Noise | 35 percent correct | Standard Deviation 0 |
Secondary
Glasgow Benefit Inventory
The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.
Time frame: 6 months post-activation
Population: subject did not reach endpoint - GBI was not collected at 3 months per protocol
Secondary
Speech, Spatial, and Qualities of Hearing Scale
The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).
Time frame: 6 months post-activation
Population: subject did not reach endpoint - SSQ was not collected at 3 months per protocol