Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Phase 4

Completed

• Conditions: Hearing Loss

• Registration Number: NCT00205881
• Lead Sponsor: Advanced Bionics

Brief Summary

Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-09-29
• Results First Submitted QC: 2012-01-09
• Status Verified: 2012-02
• Results First Posted: 2012-02-10
• Last Update Submitted: 2012-02-28
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. No previous implant experience.
2. Age 18 years or older.
3. Postlingual onset of hearing loss.
4. Sensorineural hearing loss of a severe or greater degree in both ears.
5. Normal/patent cochlear anatomy in each ear.
6. English language proficiency.
7. Willingness and ability to participate in all scheduled procedures.

Exclusion Criteria

No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.	8 months of bilateral cochlear implant use	Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.

Secondary Outcome Measures

Name	Time	Method
HINT Sentences in Noise	8 months of bilateral cochlear implant use	20 sentences presented in noise at fixed levels

Trial Locations

Locations (9)

House Clinic/House Ear Institute; 🇺🇸 Los Angeles, California, United States

California Ear Institute (Let Them Hear Foundation); 🇺🇸 Palo Alto, California, United States

University of Miami - Cochlear Implant Center; 🇺🇸 Miami, Florida, United States

Tampa Bay Hearing and Balance Center; 🇺🇸 Tampa, Florida, United States

Carle Clinic Association; 🇺🇸 Urbana, Illinois, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Midwest Ear Institute; 🇺🇸 Kansas City, Missouri, United States

New York University Cochlear Implant Center; 🇺🇸 New York, New York, United States

Dallas Otolaryngology Associates; 🇺🇸 Dallas, Texas, United States