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

Advanced Bionics

Status and phase: Completed; Phase 4

Conditions: Hearing Loss

Treatments: Device: HiRes 90K Bionic Ear System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00205881

AUD-BL-070705

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 1 patient group

1

Active Comparator group

Description:

Bilaterally Implanted with HiRes 90K device.

Treatment:

Device: HiRes 90K Bionic Ear System