Esteem Totally Implantable Hearing System

Related Clinical Trial
Dexamethasone-Eluting Cochlear Implant Electrode Artificial Intelligence in Diagnosis of DFNA9 Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC Cochlear Implant and Vestibular Function. Quality Control of CE-Certified Phonak Hearing Aids – 2018_42 Quality Control of CE-Certified Phonak Hearing Aids – 2018_28 Enlarged Vestibular Aqueduct Registry Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis Effectiveness of P02 Digital Hearing Aids ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population Genetic Analysis of Hereditary Disorders of Hearing and Balance Compassionate Use Arm – ABI541 ABI for 10 NF2 Patients Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life Evaluation of N6 Sound Processor in Group of Freedom Users Robotic Assisted Cochlear Implantation Feasibility Study Auditory Nerve Test System During Vestibular Schwannoma Resection Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors Listening Effort in Cochlear Implant Users Quality Control of CE-Certified Phonak Hearing Aids – 2019_19 Esteem Totally Implantable Hearing System A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy CI532 – Early Experience Study Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery Single-sided Deafness and Cochlear Implants Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques OTO-413 in Subjects With Speech-in-Noise Hearing Impairment The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure Clinical Evaluation of a Cochlear Implant System Objective Measures in Cochlear Implant Evaluation of a Binaural Spatialization Method for Hearing Aids Esteem New Subject Enrollment Post Approval Study Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss Investigation of Anatomical Correlates of Speech Discrimination Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts Balance in Children With Cochlear Implants Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System Radiological Classification of the Facial Nerve Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial The Effect of Sound Stimulation on Hearing Ability The Effect of Sound Stimulation on Pure-tone Hearing Threshold Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss The SeaSHeL National Prospective Cohort Study Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode Video HIT in Sudden Sensorineural Hearing Loss Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss. FX-322 in Sensorineural Hearing Loss Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss FX-322 in Adults With Stable Sensorineural Hearing Loss

Brief Title

Esteem Totally Implantable Hearing System

Official Title

Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial

Brief Summary

      To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in
      subjects suffering from mild to severe hearing loss.
    

Detailed Description

      Title: Esteem® Totally Implantable Hearing System Clinical Trial

      Purpose: To evaluate the safety and efficacy of the Esteem® Totally Implantable Hearing
      System (hereafter called the Esteem® System) in subjects suffering from mild to severe
      hearing loss.

      Trial Design: This pivotal trial is designed as a prospective, multi-center, non-randomized,
      clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the
      subject will act as his or her own control.

      This trial has been designed to meet the United States' regulatory requirements.

      Enrollment Size: It is currently estimated that 50-60 subjects will be enrolled in this
      trial.

      Subject Population: Adult subjects who have mild to severe sensorineural hearing loss, have a
      healthy middle ear, have a speech discrimination score of equal to or better than 40%, and
      have previously worn a hearing aid for a minimum of 3 months with an average daily use rate
      of at least 4 hours are eligible for inclusion in the trial. See detailed inclusion/exclusion
      criteria for specifics.

      Primary Objectives:

        1. To demonstrate that the Esteem® System improves the speech threshold of sensitivity for
           hearing and identifying speech signals as well as or better than the pre-implant hearing
           aid (aided condition).

           Endpoint: Comparison of the speech reception threshold (SRT) using the Esteem® System (4
           months post activation) as compared to the pre-implant aided condition.

        2. To demonstrate that the Esteem® System at the 4 months post- activation visit is as
           effective as or better than the hearing aid for improving speech discrimination
           (intelligibility) as shown by the word recognition score at 50 dB.

           Endpoint: Comparison of the word recognition score using the Esteem® at 4 months
           post-activation compared to the pre-implant aided condition.

        3. To determine the incidence of Serious Adverse Device Effects (SADE) and the incidence
           rate of device failures and replacements.

           Endpoint: The analysis of the incidence of SADEs and device failures and replacements at
           each follow-up.

        4. To demonstrate that the subjects' cochlear function remains unchanged with the Esteem®
           System as shown by comparison of the subjects' pre-implant baseline bone conduction
           threshold versus the subjects' 4 month post-activation visit bone conduction threshold.

      Endpoint: Comparison of bone conduction threshold (BC) using forehead placement at 4 months
      post activation compared to the pre-implant BC threshold.

      Secondary Objectives:

        1. To demonstrate that the Esteem® System at the 4 months post activation visit improves
           the 3-frequency (500, 1000, and 2000 Hz) pure tone average (PTA) when compared to the
           baseline unaided condition.

        2. To demonstrate that the Esteem® System at the 4 months post-activation visit is as
           effective as or better than the hearing aid for improving speech discrimination
           (intelligibility) as shown by the QuickSIN (speech in noise) test results.

        3. To show that the Esteem® System improves Quality-of-Life when compared to the baseline
           aided condition as shown by APHAB results.

        4. To gather subject feedback and comments on the use of the Esteem® System relative to the
           pre-implant hearing aid (aided condition) as shown by the Esteem® Questionnaire.
    


Study Type

Interventional


Primary Outcome

SRT Change

Secondary Outcome

 Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score

Condition

Mild to Severe Sensorineural Hearing Loss

Intervention

Esteem Totally Implantable Hearing System

Study Arms / Comparison Groups

 Esteem Implant
Description:  Subjects are implanted with the Esteem Totally Implantable 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

57

Start Date

January 2008

Completion Date

August 2010

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Subject is 18 years old

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

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

          -  Subject has mild to severe sensorineural hearing loss between 500 and 4000 Hz in the
             ear to be implanted with pure tone air-conduction threshold levels within the limits
             of a Hearing Aid (HA) as follow:

        Freq (Hz) 500 1000 2000 3000 4000 LL* (dB HL) 30 35 35 35 35 UL* (dB HL) 100 100 100 100
        100

        *LL = Lower Level; UL = Upper Level

          -  Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies:
             500, 1000, 2000, 3000 and 4000 Hz.

          -  Subject has an unaided maximum word recognition score of greater than or equal to 60%
             with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at
             maximum tolerable presentation level.

          -  Subject is a current user of a properly functioning and appropriately fit hearing aid.
             This is defined as the subject has used this aid for at least four (4) hours (average)
             per day (in the ear to be implanted) for at least three (3) months for a new aid or
             one (1) month for an adjusted aid.

          -  Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.

          -  Subject has normally functioning eustachian tube

          -  Subject has normal tympanic membrane

          -  Subject has a normal middle ear anatomy

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

          -  Subject is a native speaker of the English language.

          -  Subject is a hearing aid user in the ear to be implanted.

        Exclusion Criteria:

          -  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

          -  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

          -  Subject has cholesteatoma or destructive middle ear disease

          -  Subject has life expectancy of two (2) years due to other medical conditions

          -  Subject has retrocochlear or central auditory disorders

          -  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

          -  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)

          -  Subject has sudden hearing loss due to unknown cause

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

          -  Subject is unable to adequately perform audiological testing

          -  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.

          -  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

          -  Subject is pregnant at the time of device implant

          -  Subject has a history of keloid formation

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jack A. Shohet, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01092910

Organization ID

0204


Responsible Party

Sponsor

Study Sponsor

Envoy Medical Corporation


Study Sponsor

Jack A. Shohet, M.D., Principal Investigator, 


Verification Date

January 2016