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

NCT00205881 | Completed Phase 4 Results

• 1 other identifier: AUD-BL-070705
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 9

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.

Conditions

Hearing Loss

Keywords

HiResolution Bionic Ear; severe to profound hearing loss; bilateral implantation

Outcome Measures

Primary Outcomes (1)

• Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.

  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.

  8 months of bilateral cochlear implant use

Secondary Outcomes (1)

• HINT Sentences in Noise

  8 months of bilateral cochlear implant use

Study Arms (1)

1

ACTIVE COMPARATOR

Bilaterally Implanted with HiRes 90K device.

Device: HiRes 90K Bionic Ear System

Interventions

HiRes 90K Bionic Ear System DEVICE

Cochlear implant system

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Advanced Bionics: lead

Study Sites (9)

House Clinic/House Ear Institute

Los Angeles, California, 90057, United States

Location

California Ear Institute (Let Them Hear Foundation)

Palo Alto, California, 94303, United States

Location

University of Miami - Cochlear Implant Center

Miami, Florida, 33136, United States

Location

Tampa Bay Hearing and Balance Center

Tampa, Florida, 33606, United States

Location

Carle Clinic Association

Urbana, Illinois, 61801, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49546, United States

Location

Midwest Ear Institute

Kansas City, Missouri, 64108, United States

Location

New York University Cochlear Implant Center

New York, New York, 10016, United States

Location

Dallas Otolaryngology Associates

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kenneth Ripley
• Organization: Advanced Bionics, LLC

Kenneth.Ripley@advancedbionics.com

(661) 362-4572

Study Officials

• Mary Joe Osberger

  Advanced Bionics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 1, 2012
• Results First Posted: February 10, 2012

Record last verified: 2012-02

Locations

US (9)