SoundBite Hearing System 24 Month Multi Site Patient Use Study
1 other identifier
observational
75
1 country
7
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 subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.
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 Mar 2013
7 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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 3, 2013
May 1, 2013
1.4 years
March 6, 2013
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.
24 Months
Secondary Outcomes (1)
Aided Threshold Testing
24 Months
Other Outcomes (1)
Single Sided Deafness Questionnaire
24 Months
Interventions
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
All trial subjects are individuals who are already currently using SoundBite Hearing System for treatment of their SSD or CHL and were enrolled in the SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN0006). Participants are willing to participate in this study.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Arizona Ear Center
Phoenix, Arizona, 85004, United States
California Hearing and Balance
La Jolla, California, 92037, United States
Shohet Ear Associates
Newport Beach, California, 92663, United States
The George Washington University-Department of Otolaryngology
Washington D.C., District of Columbia, 20006, United States
Physicians Choice Hearing and Balance
Tampa, Florida, 33613, 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)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 8, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 3, 2013
Record last verified: 2013-05