Esteem New Subject Enrollment Post Approval Study

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Brief Title

Esteem New Subject Enrollment Post Approval Study

Official Title

Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

Brief Summary

      The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the
      Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe
      hearing loss.
    

Detailed Description

      Purpose:

      To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing
      System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss.

      Questions:

      The following questions are to be answered:

        -  Is Esteem effective through 1 year follow-up?

        -  Is Esteem safe through 1 year follow-up?

        -  Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?
    


Study Type

Interventional


Primary Outcome

Change in Speech Reception Threshold (SRT)

Secondary Outcome

 Change in Subjective Quality of Life as Measured with APHAB

Condition

Sensorineural Hearing Loss

Intervention

Implantation of Esteem

Study Arms / Comparison Groups

 Esteem Implant
Description:  Implantation of Esteem

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

120

Start Date

August 2010

Completion Date

January 2022

Primary Completion Date

January 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Subject is ≥ 18 years old

          2. Subject understands the nature of the procedure and has signed the Subject Informed
             Consent Form prior to the procedure

          3. Subject is willing and able to comply with specified follow-up evaluations and
             understands the audiological test procedures and use of the Esteem® System.

          4. Subject has moderate to severe sensorineural hearing loss in the ear to be implanted
             defined by pure tone average air-conduction threshold level.

          5. Subject has an unaided maximum word recognition score of greater than or equal to 40%
             with recorded delivery using a phonetically balanced word list at SRT + 40 decibels
             (dB) or at maximum tolerable presentation level.

          6. Subject is a current user of a properly functioning and appropriately fit hearing aid
             for at least one (1) month in the ear to be implanted.

          7. Subject has normally functioning eustachian tube

          8. Subject has normal tympanic membrane

          9. Subject has a normal middle ear anatomy

         10. Subject has adequate space for Esteem® System implant determined via fine cut temporal
             bone CT scan

         11. Subject is a native speaker of the English language.

        Exclusion Criteria:

          1. Subject has a history of post-adolescent chronic middle ear infections, inner ear
             disorders or recurring vertigo requiring treatment, disorders such as mastoiditis,
             Hydrops or Meniere's syndrome or disease

          2. Subject has a history of otitis externa or eczema for the outer ear canal and the
             investigator believes this will affect the Esteem® System implantation

          3. Subject has cholesteatoma or destructive middle ear disease

          4. Subject has life expectancy of < two (2) years due to other medical conditions

          5. Subject has retrocochlear or central auditory disorders

          6. Subject is known to be suffering from any psychological, developmental, physical, or
             emotional disorder that the investigator feels would interfere with the surgery or
             follow-up testing

          7. Subject has a known history of fluctuating air conduction and/or bone conduction
             hearing loss over a one-year period of 15 dB in either direction at 2 or more
             frequencies (from 500 - 4000 Hz)

          8. Subject has sudden hearing loss due to unknown cause

          9. Subject has a history of disabling tinnitus, defined as tinnitus which required
             treatment.

         10. Subject is unable to adequately perform audiological testing

         11. Subject has a medical condition or undergoing a treatment that may affect healing and
             the investigator does not believe the subject is a good candidate for the trial.

         12. Subject has diabetes that is not well controlled with medication or diet and the
             investigator does not believe in his best medical judgment that the subject would be a
             good candidate for the trial

         13. Subject is pregnant at the time of device implant

         14. Subject has a history of keloid formation

         15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel,
             titanium and/or gold
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sam Marzo, MD, , [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02689349

Organization ID

0205


Responsible Party

Sponsor

Study Sponsor

Envoy Medical Corporation


Study Sponsor

Sam Marzo, MD, Principal Investigator, Loyola Center for Hearing, Woodridge IL


Verification Date

July 2019