MedTrace Logo

Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

NCT01975571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.

Conditions

  • Hearing Loss, High-Frequency

Interventions

DEVICE

Cochlear® Nucleus™ Hybrid L24

The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.

DEVICE

Cochlear® Nucleus™ Hybrid S12

The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.

Sponsors & Collaborators

  • Bruce J Gantz

    lead OTHER

Principal Investigators

  • Bruce Gantz, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2018-09-08
Completion
2018-09-08

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975571 on ClinicalTrials.gov