An interventional study of Hybrid SRW cochlear implant in Sensorineural Hearing Loss, sponsored by Cochlear. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by Cochlear · Interventional and Treatment
Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.
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
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be implanted with the Hybrid SRW cochlear implant.
Device: Hybrid SRW cochlear implant
Subjects will be implanted with the Hybrid SRW
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
| Milestone | Implanted |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| percentage of correct words. | Implanted |
|---|---|
| CNC (Consonant-nucleus-consonant) Words | 64.8 ± 23.0 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implanted | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Event | Implanted |
|---|---|
| Sudden hearing threshold shift resulting in profound hearing lossEar and labyrinth disorders | 1/6 |
| Significant decrease in hearing thresholds (20-35dB)Ear and labyrinth disorders | 1/6 |
| Skin Flap sorenessSkin and subcutaneous tissue disorders | 1/6 |
| Open circuit electrodesProduct Issues | 1/6 |
| bronchitisRespiratory, thoracic and mediastinal disorders | 1/6 |
| Increased tinnitusEar and labyrinth disorders | 1/6 |
| external otitisEar and labyrinth disorders | 1/6 |
| Age, Customized(Participants) | Implanted |
|---|---|
| Count of participants | 6 |
| Sex: Female, Male(Participants) | Implanted |
|---|---|
| Female | 3 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Implanted |
|---|
| Region of Enrollment(participants) | Implanted |
|---|---|
| United States | 6 |
| Age at Implant in Years(years) | Implanted |
|---|---|
| Mean | 57.5 ± 11.0 |
| Duration of Hearing Loss(years) | Implanted |
|---|---|
| Mean | 37.8 ± 25.2 |
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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