Status:
UNKNOWN
SoundBite Hearing System Long Term Multi Site Patient Use Study
Lead Sponsor:
Sonitus Medical Inc
Conditions:
Single Sided Deafness
Conductive Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to collect data about the SoundBite™ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administra...
Detailed Description
The Sonitus SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus...
Eligibility Criteria
Inclusion
- Patients who are 18 years or older
- 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
- 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 sue their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01445977
Start Date
September 1 2011
End Date
September 1 2013
Last Update
August 2 2013
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Ear Center
Phoenix, Arizona, United States, 85004
2
California Hearing and Balance Center
La Jolla, California, United States, 92037
3
Shohet Ear Associates Medical Group
Newport Beach, California, United States, 92663
4
Camino Ear, Nose and Throat Clinic
San Jose, California, United States, 95138