SoundBite Hearing System 24 Month Multi Site Patient Use Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sonitus Medical Inc
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01807559
First received: March 6, 2013
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.


Condition Intervention
Single Sided Deafness
Conductive Hearing Loss
Device: SoundBite Hearing System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SoundBite Hearing System 24 Month Multi Site Patient Use Study

Resource links provided by NLM:


Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.


Secondary Outcome Measures:
  • Aided Threshold Testing [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System


Other Outcome Measures:
  • Single Sided Deafness Questionnaire [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    This questionnaire assesses quality of life outcomes.


Estimated Enrollment: 75
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SoundBite Hearing System
    The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical 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 software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical 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 who are already currently using SoundBite Hearing System for treatment of their SSD or CHL and were enrolled in the SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN0006). Participants are willing to participate in this study.

Criteria

Inclusion Criteria:

  • Subjects who previously were enrolled in SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN006) and completed the 12 month study visit.
  • Additionally, subjects must meet one of the two criteria for hearing loss:

    1. Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). 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.

      OR

    2. 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.

Exclusion Criteria:

  • Subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for Protocol CLN006:

    1. A moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or ―SSD‖). 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.
    2. Patients 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

      • 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 use 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: NCT01807559

Contacts
Contact: Linda Galow, MS 832-434-9730 linda@sonitusmedical.com

Locations
United States, Arizona
Arizona Ear Center Recruiting
Phoenix, Arizona, United States, 85004
Contact: Kelly Hernanadez, AuD    602-307-9919    audiology@arizonaear.com   
Principal Investigator: Mark Syms, MD         
United States, California
California Hearing and Balance Recruiting
La Jolla, California, United States, 92037
Contact: Sara Mattson, AuD    858-909-0770      
Principal Investigator: Ritvik Mehta, MD         
Shohet Ear Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Cheryl Tanita, AuD    949-631-4327    ctanita@eardoctor.org   
Principal Investigator: Jack Shohet, MD         
United States, District of Columbia
The George Washington University-Department of Otolaryngology Not yet recruiting
Washington, District of Columbia, United States, 20006
Contact: Rachel Lazaro, AuD    202-741-3275    rlazaro@mfa.gwu.edu   
Principal Investigator: Ashkan Monfared, MD         
United States, Florida
Physicians Choice Hearing and Balance Recruiting
Tampa, Florida, United States, 33613
Contact: Jeffrey Clark, AuD    813-558-1477      
Principal Investigator: Jeffrey Clark, AuD         
United States, Texas
Ear Medical Group Recruiting
San Antonio, Texas, United States, 78240
Contact: Robyn Shanley, PhD    210-614-6070    RobynS@earmedicalgroup.com   
Principal Investigator: Charles Syms, MD         
United States, Utah
University Health Science Center (University of Utah Hospital) Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Diane Tyler, RN    801-587-4824    diane.tyler@hsc.utah.edu   
Principal Investigator: Richard Gurgel, MD         
Sponsors and Collaborators
Sonitus Medical Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01807559     History of Changes
Other Study ID Numbers: CLN009
Study First Received: March 6, 2013
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administation

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

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

ClinicalTrials.gov processed this record on October 20, 2014