Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy

Mass Eye and Ear

Status: Enrolling

Conditions: Cochlear Hearing Loss; Deafness

Treatments: Other: Population mean mapping; Other: Changes in traditional follow-up

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06960616

2024P000034

Details and patient eligibility

About

The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postlingually deafened
• Adults (18+)
• New cochlear implant recipients with Cochlear Americas devices; identified prior to activation
• Able to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires)
• English speakers

Exclusion criteria

• Patients who select other cochlear implant manufactured devices
• Pre-lingually deafened
• Multiple disabilities
• Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires)
• Non-English speakers
• Children under the age of 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 4 patient groups

Population mean mapping, without 1 week follow-up

Experimental group

Description:

Reduction in the number of follow-up visits and new programming strategy.

Treatment:

Other: Changes in traditional follow-up

Other: Population mean mapping

Population mean mapping, traditional follow-up

Experimental group

Description:

New programming strategy

Treatment:

Other: Population mean mapping

Traditional mapping*, without 1 week follow-up

Experimental group

Description:

Reduction in the number of follow-up visits.

Treatment:

Other: Changes in traditional follow-up

Traditional mapping, traditional follow-up

No Intervention group

Description:

Traditional follow-up plan