SoundBite Hearing System Long Term Multi Site Patient Use Study

• ClinicalTrials.gov Identifier: NCT01445977
• Recruitment Status: Unknown
• First Posted: October 4, 2011
• Last Update Posted: August 2, 2013
• Sponsor: Sonitus Medical Inc
• Information provided by (Responsible Party): Sonitus Medical Inc

Tracking Information

• First Submitted Date: September 28, 2011
• First Posted Date: October 4, 2011
• Last Update Posted Date: August 2, 2013
• Study Start Date: September 2011
• Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 30, 2011)

• Aided Threshold Testing [ Time Frame: 12 months ]
  Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System
• Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [ Time Frame: 12 months ]
  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
• Single Sided Deafness Questionnaire [ Time Frame: 12 months ]
  This questionnaire assesses qualitative outcomes.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SoundBite Hearing System Long Term Multi Site Patient Use Study
• Official Title: SoundBite Hearing System Long Term Multi Site Patient Use Study
• 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).
• 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 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 calibration software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this multi-sites observational study is to assess the long-term patient use of the Sonitus SoundBite Hearing System.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 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.

Condition

• Single Sided Deafness
• Conductive Hearing Loss

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 30, 2011): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2013
• Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01445977
• Other Study ID Numbers: CLN006
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sonitus Medical Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Sonitus Medical Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gerald Popelka, PhD; Stanford University

• PRS Account: Sonitus Medical Inc
• Verification Date: August 2013