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SoundBite Hearing System Long Term Multi Site Patient Use Study

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ClinicalTrials.gov Identifier: NCT01445977
Recruitment Status : Unknown
Verified August 2013 by Sonitus Medical Inc.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2011
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc

September 28, 2011
October 4, 2011
August 2, 2013
September 2011
September 2013   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01445977 on ClinicalTrials.gov Archive Site
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SoundBite Hearing System Long Term Multi Site Patient Use Study
SoundBite Hearing System Long Term Multi Site Patient Use Study
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).
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Single Sided Deafness
  • Conductive Hearing Loss
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
Same as current
September 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01445977
CLN006
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Sonitus Medical Inc
Sonitus Medical Inc
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Principal Investigator: Gerald Popelka, PhD Stanford University
Sonitus Medical Inc
August 2013