SoundBite Hearing System 24 Month Multi Site Patient Use Study
NCT ID: NCT01807559
Last Updated: 2013-05-03
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
75 participants
OBSERVATIONAL
2013-03-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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SoundBite Hearing System
The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical SoundBite Hearing System consists of an In-the-Mouth (ITM) component, an external microphone component worn behind the ear (BTE), a calibration interface cable and PC-controlled software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical SoundBite Hearing System.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Sonitus Medical Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Sara Mattson, AuD
Role: primary
Jeffrey Clark, AuD
Role: primary
Related Links
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Related Info
Other Identifiers
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CLN009
Identifier Type: -
Identifier Source: org_study_id
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