SoundBite Hearing System Long Term Multi Site Patient Use Study
This study is ongoing, but not recruiting participants.
Sponsor:
Sonitus Medical Inc
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01445977
First received: September 28, 2011
Last updated: July 5, 2012
Last verified: July 2012
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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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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
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: | July 5, 2012 |
| 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 May 19, 2013