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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205881
• Other study ID #: AUD-BL-070705
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 28, 2012
• Start date: October 2004
• Est. completion date: May 2009

Study information

• Verified date: February 2012
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• HiRes 90K Bionic Ear System
Cochlear implant system

Locations

Country	Name	City	State
United States	Dallas Otolaryngology Associates	Dallas	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Midwest Ear Institute	Kansas City	Missouri
United States	House Clinic/House Ear Institute	Los Angeles	California
United States	University of Miami - Cochlear Implant Center	Miami	Florida
United States	New York University Cochlear Implant Center	New York	New York
United States	California Ear Institute (Let Them Hear Foundation)	Palo Alto	California
United States	Tampa Bay Hearing and Balance Center	Tampa	Florida
United States	Carle Clinic Association	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	HINT Sentences in Noise	20 sentences presented in noise at fixed levels	8 months of bilateral cochlear implant use	No