SoundBite Hearing System Long Term Multi Site Patient Use Study

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Brief Title

SoundBite Hearing System Long Term Multi Site Patient Use Study

Official Title

SoundBite Hearing System Long Term Multi Site Patient Use Study

Brief Summary

      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).
    

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


Primary Outcome

Aided Threshold Testing


Condition

Single Sided Deafness



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

September 2011

Completion Date

September 2013

Primary Completion Date

September 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gerald Popelka, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01445977

Organization ID

CLN006


Responsible Party

Sponsor

Study Sponsor

Sonitus Medical Inc


Study Sponsor

Gerald Popelka, PhD, Principal Investigator, Stanford University


Verification Date

August 2013