An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Related Clinical Trial
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

An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Official Title

An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients

Brief Summary

      The clinical investigation is evaluating a new clinical model in a group of newly implanted
      subjects who have already been consented to CI surgery.
    



Study Type

Interventional


Primary Outcome

Change in time spent with audiologist


Condition

Sensorineural Hearing Loss, Bilateral

Intervention

Clinical Education and Treatment Model

Study Arms / Comparison Groups

 Group A - New Model
Description:  Standardized programming and testing method

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

Other

Estimated Enrollment

4

Start Date

February 26, 2019

Completion Date

October 29, 2019

Primary Completion Date

October 29, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes

          -  18 years and older

          -  Postlingual onset of hearing loss (onset of hearing loss >two years of age)

          -  Individuals who qualify for cochlear implantation using the clinics current CI
             candidacy criteria

          -  Individuals who have recently been implanted but not yet had their external device
             activated

          -  Willingness to participate in a study and comply with all study requirements

          -  Fluent in spoken English

        Exclusion Criteria:

          -  Ossification or any other cochlear anomaly that might prevent insertion of less than
             10 electrodes of the electrode array

          -  Diagnosis of retro-cochlear pathology

          -  Diagnosis of auditory neuropathy

          -  Subject considering an acoustic component in the implanted ear

          -  Unrealistic expectations on the part of the subject regarding the possible benefits,
             risks, and limitations that are inherent to the surgical procedure and use of the
             prosthetic device

          -  Unwillingness or inability to comply with all investigational requirements

          -  Severe-profound sensorineural hearing loss >30 years

          -  Previous cochlear implant in the contralateral ear. Additional cognitive, medical or
             social handicaps that would prevent completion of all study requirements as determined
             by the investigator
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03904420

Organization ID

CAM5753


Responsible Party

Sponsor

Study Sponsor

Cochlear


Study Sponsor

, , 


Verification Date

January 2020