NCT02638883

Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	Hybrid SRW cochlear implant	Subjects will be implanted with the Hybrid SRW

Timeline

• Start date: 2016-02-08
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2015-12-23
• Last updated: 2022-09-27
• Results posted: 2022-09-27

Locations

1 site across 1 country: United States