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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Bilaterally Implanted with HiRes 90K device.

Group Type ACTIVE_COMPARATOR

HiRes 90K Bionic Ear System

Intervention Type DEVICE

Cochlear implant system

Interventions

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HiRes 90K Bionic Ear System

Cochlear implant system

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No