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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

House Clinic/House Ear Institute, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

HiRes 90K Bionic Ear System

Device

Cochlear implant system

Primary outcomes

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

Time frame: 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 outcomes

HINT Sentences in Noise

Time frame: 8 months of bilateral cochlear implant use

20 sentences presented in noise at fixed levels

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Sep 21, 2005
Registry last updated: Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed