SoundBite Hearing System Long Term Multi Site Patient Use Study

August 1, 2013 updated by: Sonitus Medical Inc
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).

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona Ear Center
    • California
      • LaJolla, California, United States, 92037
        • California Hearing and Balance Center
      • Newport Beach, California, United States, 92663
        • Shohet Ear Associates Medical Group
      • San Jose, California, United States, 95138
        • Camino Ear, Nose and Throat Clinic
      • San Mateo, California, United States, 94401
        • Hearing Resource Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • The George Washington University- Department of Otolaryngology
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Miller School of Medicine
      • Tampa, Florida, United States, 33613
        • Physicians Choice Hearing and Dizziness Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System- Department of Otolayrngology and Audiology
    • New York
      • New York, New York, United States, 10021
        • New York Otology
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Carolina Ear and Hearing Clinic, PC
    • Texas
      • San Antonio, Texas, United States, 78240
        • Ear Medical Group
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University Health Science Center (University of Utah Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
Single Sided Deafness Questionnaire
Time Frame: 12 months
This questionnaire assesses qualitative outcomes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonitus Medical Inc

Investigators

  • Principal Investigator: Gerald Popelka, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (ESTIMATE)

October 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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