Sensorineural Hearing Loss
Conditions
Keywords
Adults; high frequency SNHL
Brief summary
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
Detailed description
The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant System (P130016) for individuals aged 18 years and older who present with bilateral residual low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss with limited benefit from appropriately fitted bilateral amplification. Additionally, the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is designed to support implantation via a round window (RW) approach while maintaining the same relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy
Interventions
DEVICEHybrid SRW cochlear implant
Subjects will be implanted with the Hybrid SRW
Sponsors
University of Iowa
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Eighteen years of age or older at the time of implantation 2. Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, & 4000 Hz) of \> 60dB HL. 3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below 4. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted 5. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80% 6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation
Exclusion criteria
1. Individuals aged greater than 75 years 2. Duration of severe to profound hearing loss (above 2kHz) greater than 20 years 3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator 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 500 to 1000 Hz 6. Deafness due to lesions of the acoustic nerve or central auditory pathway 7. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease 8. 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 as determined by the Investigator 9. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator 10. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CNC (Consonant-nucleus-consonant) Words | 12 months | Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted Subjects will be implanted with the Hybrid SRW cochlear implant.
Hybrid SRW cochlear implant: Subjects will be implanted with the Hybrid SRW | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Implanted | — |
|---|---|---|
| Age at Implant in Years | 57.5 years STANDARD_DEVIATION 11 | — |
| Age, Customized | 6 Participants | — |
| Duration of Hearing Loss | 37.8 years STANDARD_DEVIATION 25.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 6 participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
CNC (Consonant-nucleus-consonant) Words
Two CNC( consonant-nucleus-consonant) Word lists (Peterson & Lehiste, 1962) were administered in quiet at a level of 60 dBA in the sound-field and scored as a total number of words correct, expressed as a percentage. Possible score are range from 0% to 100 % words correctly repeated. Higher scores mean a better outcome.
Time frame: 12 months
Population: Only 5 subjects were analysed rather than 6 as one subject used electric mode only by 12 months post activation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implanted | CNC (Consonant-nucleus-consonant) Words | 64.8 percentage of correct words. | Standard Deviation 23 |