SoundBite Hearing System 24 Month Multi Site Patient Use Study

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Brief Title

SoundBite Hearing System 24 Month Multi Site Patient Use Study

Official Title

SoundBite Hearing System 24 Month Multi Site Patient Use Study

Brief Summary

      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 Type

Observational


Primary Outcome

Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

Secondary Outcome

 Aided Threshold Testing

Condition

Single Sided Deafness

Intervention

SoundBite Hearing System


Publications

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

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

75

Start Date

March 2013

Completion Date

August 2014

Primary Completion Date

August 2014

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 832-434-9730, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01807559

Organization ID

CLN009


Responsible Party

Sponsor

Study Sponsor

Sonitus Medical Inc


Study Sponsor

, , 


Verification Date

May 2013