SoundBite Hearing System Long Term Multi Site Patient Use Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01445977
First received: September 28, 2011
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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).


Condition
Single Sided Deafness
Conductive Hearing Loss

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SoundBite Hearing System Long Term Multi Site Patient Use Study

Resource links provided by NLM:


Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • Aided Threshold Testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This questionnaire assesses qualitative outcomes.


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445977

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

Additional Information:
No publications provided

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01445977     History of Changes
Other Study ID Numbers: CLN006
Study First Received: September 28, 2011
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sonitus Medical Inc:
Sonitus Medical
SoundBite
Single Sided Deafness
Conductive Hearing Loss
Unilateral Hearing Loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014