NCT02189798

Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Advanced Bionics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Conditions

• Hearing Loss
• Partial Deafness
• Hearing Disorders
• Ear Diseases
• Otorhinolaryngologic Diseases

Interventions

Type	Name	Description
DEVICE	HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode	HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
DEVICE	EAS sound processor	Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

Timeline

• Start date: 2014-10-21
• Primary completion: 2022-03-29
• Completion: 2022-03-29
• First posted: 2014-07-15
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study