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

Not Applicable
Terminated
Conditions
Sensorineural Hearing Loss, Bilateral
Interventions
Other: Clinical Education and Treatment Model
Other: Traditional Model
Registration Number
NCT03904420
Lead Sponsor
Cochlear
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A - New ModelClinical Education and Treatment ModelStandardized programming and testing method
Group B - Traditional ModelTraditional ModelTraditional clinical model which is not standardized across clinical sites
Primary Outcome Measures
NameTimeMethod
Change in Time Spent With Audiologist6 months post activation

Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Head and Neck Surgical Associates

🇺🇸

Wichita Falls, Texas, United States

Puget Sound ENT

🇺🇸

Edmonds, Washington, United States

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