SoundBite Hearing System Long Term Multi Site Patient Use Study
1 other identifier
observational
150
1 country
13
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 Administration (FDA). Sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 2, 2013
August 1, 2013
2 years
September 28, 2011
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Aided Threshold Testing
Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System
12 months
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A - New Format, Hearing Aid Research Lab, University of Memphis, 1994) score at 12 months compared to baseline
12 months
Single Sided Deafness Questionnaire
This questionnaire assesses qualitative outcomes.
12 months
Eligibility Criteria
All trial subjects are individuals that have decided to purchase SoundBite Hearing System for treatment of their Single Sided Deafness or Conductive Hearing Loss and are willing to participate in this study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Arizona Ear Center
Phoenix, Arizona, 85004, United States
California Hearing and Balance Center
La Jolla, California, 92037, United States
Shohet Ear Associates Medical Group
Newport Beach, California, 92663, United States
Camino Ear, Nose and Throat Clinic
San Jose, California, 95138, United States
Hearing Resource Center
San Mateo, California, 94401, United States
The George Washington University- Department of Otolaryngology
Washington D.C., District of Columbia, 20006, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Physicians Choice Hearing and Dizziness Center
Tampa, Florida, 33613, United States
Henry Ford Health System- Department of Otolayrngology and Audiology
Detroit, Michigan, 48202, United States
New York Otology
New York, New York, 10021, United States
Carolina Ear and Hearing Clinic, PC
Raleigh, North Carolina, 27612, United States
Ear Medical Group
San Antonio, Texas, 78240, United States
University Health Science Center (University of Utah Hospital)
Salt Lake City, Utah, 84132, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Popelka, PhD
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 4, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 2, 2013
Record last verified: 2013-08