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

Cochlear

Status: Terminated

Conditions: Sensorineural Hearing Loss, Bilateral

Treatments: Other: Traditional Model; Other: Clinical Education and Treatment Model

Study type: Interventional

Funder types: Industry

Identifiers

NCT03904420

CAM5753

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Group A - New Model

Experimental group

Description:

Standardized programming and testing method

Treatment:

Other: Clinical Education and Treatment Model

Group B - Traditional Model

Active Comparator group

Description:

Traditional clinical model which is not standardized across clinical sites

Treatment:

Other: Traditional Model