Status:
UNKNOWN
SoundBite Hearing System 24 Month Multi Site Patient Use Study
Lead Sponsor:
Sonitus Medical Inc
Conditions:
Single Sided Deafness
Conductive Hearing Loss
Eligibility:
All Genders
18+ years
Brief 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 subj...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- 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:
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01807559
Start Date
March 1 2013
End Date
August 1 2014
Last Update
May 3 2013
Active Locations (7)
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
La Jolla, California, United States, 92037
3
Shohet Ear Associates
Newport Beach, California, United States, 92663
4
The George Washington University-Department of Otolaryngology
Washington D.C., District of Columbia, United States, 20006