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SoundBite Hearing System 24 Month Multi Site Patient Use Study | Clinical Trials | Clareo Health

UNKNOWN

SoundBite Hearing System 24 Month Multi Site Patient Use Study

NCT01807559•Sonitus Medical Inc

Summary

The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who previously were enrolled in SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN006) and completed the 12 month study visit.
•Additionally, subjects must meet one of the two criteria for hearing loss:
•1. Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
•OR
•2. Conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.

Exclusion Criteria

•Subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for Protocol CLN006:
•1. A moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or -SSD‖). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
•2. Patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL
•* The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure
•* The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.
•* The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Locations (7)

Arizona Ear Center

Phoenix, Arizona, United States

California Hearing and Balance

La Jolla, California, United States

Shohet Ear Associates

Newport Beach, California, United States

The George Washington University-Department of Otolaryngology

Washington D.C., District of Columbia, United States

Physicians Choice Hearing and Balance

Tampa, Florida, United States

Ear Medical Group

San Antonio, Texas, United States

University Health Science Center (University of Utah Hospital)

Salt Lake City, Utah, United States

Key Dates

Start Date

March 1, 2013

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

May 3, 2013

Enrollment

ESTIMATED participants

Conditions

Single Sided DeafnessConductive Hearing Loss

Interventions

SoundBite Hearing System

DEVICE

Contacts

Linda Galow, MS

CONTACT

832-434-9730 linda@sonitusmedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SoundBite Hearing System 24 Month Multi Site Patient Use Study

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