SoundBite Hearing System 24 Month Multi Site Patient Use Study

May 2, 2013 updated by: Sonitus Medical Inc
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Arizona Ear Center
        • Contact:
        • Principal Investigator:
          • Mark Syms, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • California Hearing and Balance
        • Contact:
          • Sara Mattson, AuD
          • Phone Number: 858-909-0770
        • Principal Investigator:
          • Ritvik Mehta, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Shohet Ear Associates
        • Contact:
        • Principal Investigator:
          • Jack Shohet, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Not yet recruiting
        • The George Washington University-Department of Otolaryngology
        • Contact:
        • Principal Investigator:
          • Ashkan Monfared, MD
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Physicians Choice Hearing and Balance
        • Contact:
          • Jeffrey Clark, AuD
          • Phone Number: 813-558-1477
        • Principal Investigator:
          • Jeffrey Clark, AuD
    • Texas
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Ear Medical Group
        • Contact:
        • Principal Investigator:
          • Charles Syms, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University Health Science Center (University of Utah Hospital)
        • Principal Investigator:
          • Richard Gurgel, MD
        • Contact:

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 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.

Description

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.

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
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Time Frame: 24 Months
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.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aided Threshold Testing
Time Frame: 24 Months
Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System
24 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Sided Deafness Questionnaire
Time Frame: 24 Months
This questionnaire assesses quality of life outcomes.
24 Months

Collaborators and Investigators

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

Sponsor

Sonitus Medical Inc

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

March 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN009

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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