SoundBite Hearing System Long Term Multi Site Patient Use Study
NCT ID: NCT01445977
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2011-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of a Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (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)
* Patients diagnosed 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.
* At least two contiguous molar or premolar teeth with no untreated tooth decay. -Patients with tooth decay present are to first have restorations before being fitted for SoundBite
* Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
* No mobile teeth
* Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.
Exclusion Criteria
* 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 sue their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.
18 Years
ALL
No
Sponsors
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Sonitus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Gerald Popelka, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Arizona Ear Center
Phoenix, Arizona, United States
California Hearing and Balance Center
La Jolla, California, United States
Shohet Ear Associates Medical Group
Newport Beach, California, United States
Camino Ear, Nose and Throat Clinic
San Jose, California, United States
Hearing Resource Center
San Mateo, California, United States
The George Washington University- Department of Otolaryngology
Washington D.C., District of Columbia, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
Physicians Choice Hearing and Dizziness Center
Tampa, Florida, United States
Henry Ford Health System- Department of Otolayrngology and Audiology
Detroit, Michigan, United States
New York Otology
New York, New York, United States
Carolina Ear and Hearing Clinic, PC
Raleigh, North Carolina, United States
Ear Medical Group
San Antonio, Texas, United States
University Health Science Center (University of Utah Hospital)
Salt Lake City, Utah, United States
Countries
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Related Links
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Related Info
Other Identifiers
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CLN006
Identifier Type: -
Identifier Source: org_study_id