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

Sensorineural Hearing Loss, Bilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03904420
• Other study ID #: CAM5753
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: October 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss, Bilateral

Intervention

Other:
• Clinical Education and Treatment Model
Patients will have self directed equipment education and standardized programming approaches
• Traditional Model
Standard clinical practice and education

Locations

Country	Name	City	State
United States	Puget Sound ENT	Edmonds	Washington
United States	Head and Neck Surgical Associates	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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