Ambispective Clinical Evaluation of Sophono™

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Brief Title

Ambispective Clinical Evaluation of Sophono™

Official Title

Ambispective Clinical Evaluation of Sophono™

Brief Summary

      Study to accumulate post-market clinical evidence for the safety and effectiveness of the
      Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss,
      single-sided deafness and mixed hearing loss who currently have or have had the Sophono
      implant.
    



Study Type

Observational


Primary Outcome

Assess the safety of the Sophono implant

Secondary Outcome

 Compare the effectiveness of the Sophono Alpha 2 processor to the Alpha 2 MPO processor

Condition

Conductive Hearing Loss

Intervention

Sophono Bone Conduction Hearing Systems

Study Arms / Comparison Groups

 Subjects
Description:  Diagnosed with CHL, SSD and mixed HL who currently have or have had the Sophono implant

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

71

Start Date

June 29, 2017

Completion Date

May 31, 2018

Primary Completion Date

May 31, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Any subject who currently has or who has had the Sophono implant (including those who
             have been explanted)

          -  Has or has had Sophono implant for 3 months or longer

        Exclusion Criteria:

          -  Subject has implant but is unable or unwilling to perform audiologic testing

          -  Subject is currently participating in another clinical study and has not been approved
             for concurrent enrollment by the Study Sponsor
      

Gender

All

Ages

5 Years - N/A


Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03143257

Organization ID

MDT16043ENT


Responsible Party

Sponsor

Study Sponsor

Medtronic Surgical Technologies


Study Sponsor

, , 


Verification Date

June 2018