Osia CPT Code Study

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Brief Title

Osia CPT Code Study

Official Title

A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.

Brief Summary

      To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed
      conductive hearing loss in a US cohort.
    



Study Type

Interventional


Primary Outcome

Adaptive speech in noise test for Osia 2 system.

Secondary Outcome

 Aided vs unaided differences between the Osia and Connect arms

Condition

Conductive Hearing Loss

Intervention

Osia 2 System

Study Arms / Comparison Groups

 Osia 2 System
Description:  Osia 2 Active Osseointegrated Implant System for Bone Conduction

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

60

Start Date

April 15, 2020

Completion Date

February 28, 2021

Primary Completion Date

November 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Cohort 1 Osia:

               -  Willing and able to provide written informed consent.

               -  Proficient in English.

               -  Hearing loss etiology of Conductive or Mixed Conductive loss.

               -  Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the
                  treatment ear.

               -  Aged 18 years and older.

        Cohort 2 Connect:

          -  Willing and able to provide written informed consent.

          -  Proficient in English.

          -  Hearing loss etiology of Conductive or Mixed Conductive loss.

          -  Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the
             treatment ear

          -  Aged 18 years and older.

          -  Minimum 3 months duration of use with an appropriately fitted Baha Connect bone
             conduction device.

        Exclusion Criteria:

          -  Cohort 1 Osia:

               -  Unwilling to wear the treatment device or comply with the surgical and
                  rehabilitation requirements of the study.

               -  Unable or unwilling to comply with the requirements of the clinical investigation
                  as determined by the Investigator.

               -  Medical, audiological or psychological conditions, as judged by the investigator
                  that might contraindicate participation in the clinical investigation.

               -  Investigator site personnel directly affiliated with this study and/or their
                  immediate families; immediate family is defined as a spouse, parent, child, or
                  sibling.

               -  Cochlear employees or contractors engaged by Cochlear for the purposes of this
                  investigation.

               -  Currently participating, or participated within the last 30 days, in another
                  interventional clinical investigation/trial involving an investigational drug or
                  device.

               -  Prior experience with a surgical bone conduction treatment option

               -  Insufficient bone quality to support the BI300 implant as determined by the
                  surgeon

        Cohort 2 Connect:

          -  Unwilling to wear the treatment device or comply with the surgical and rehabilitation
             requirements of the study.

          -  Unable or unwilling to comply with the requirements of the clinical investigation as
             determined by the Investigator.

          -  Medical, audiological or psychological conditions, as judged by the investigator that
             might contraindicate participation in the clinical investigation.

          -  Investigator site personnel directly affiliated with this study and/or their immediate
             families; immediate family is defined as a spouse, parent, child, or sibling.

          -  Cochlear employees or contractors engaged by Cochlear for the purposes of this
             investigation.

          -  Currently participating, or participated within the last 30 days, in another
             interventional clinical investigation/trial involving an investigational drug or
             device.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mark Syms, MD, 303 885 5440, [email protected]



Administrative Informations


NCT ID

NCT04320407

Organization ID

CAM5778


Responsible Party

Sponsor

Study Sponsor

Cochlear


Study Sponsor

Mark Syms, MD, Principal Investigator, Arizona Hearing Center


Verification Date

March 2020