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

NCT03904420 | Terminated Results

• 1 other identifier: CAM5753
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Sensorineural Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (1)

• Change in Time Spent With Audiologist

  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).

  6 months post activation

Study Arms (2)

Group A - New Model

EXPERIMENTAL

Standardized programming and testing method

Other: Clinical Education and Treatment Model

Group B - Traditional Model

ACTIVE COMPARATOR

Traditional clinical model which is not standardized across clinical sites

Other: Traditional Model

Interventions

Clinical Education and Treatment Model OTHER

Patients will have self directed equipment education and standardized programming approaches

Group A - New Model

Traditional Model OTHER

Standard clinical practice and education

Group B - Traditional Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (2)

Head and Neck Surgical Associates

Wichita Falls, Texas, 76310, United States

Location

Puget Sound ENT

Edmonds, Washington, 98026, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Chenier
• Organization: Cochlear Limited

lchenier@cochlear.com

+14423254171

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: February 26, 2019
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: October 29, 2020
• Results First Posted: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)