Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06960616

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

Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-05-09

48

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

M

Massachusetts Eye and Ear Infirmary

Lead Sponsor

C

Cochlear

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Postlingually deafened
  • Adults 18 years and older
  • New cochlear implant recipients with Cochlear Americas devices, identified before activation
  • Able to perform follow-up testing tasks such as repeating words or sentences, indicating hearing of sound stimuli, and completing questionnaires
  • English speakers
Not Eligible

You will not qualify if you...

  • Patients who select cochlear implant devices from manufacturers other than Cochlear Americas
  • Pre-lingually deafened individuals
  • Individuals with multiple disabilities
  • Unable to perform follow-up testing tasks such as repeating words or sentences, indicating hearing of sound stimuli, or completing questionnaires
  • Non-English speakers
  • Children under 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mass Eye and Ear

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Arenberg

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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