Outcome Prediction in Cochlear Implant Recipients

Prediction of Outcomes in Adult Cochlear Implant Recipients

The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Cochlear implant

• Study Type: Observational
• Enrollment (Actual): 267

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • The HEARing CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult Cochlear Implant Recipients

Description

Inclusion Criteria:

1. Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
2. Willing and able to attend the study visits
3. Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
4. Able to read and understand study documents and follow investigator instructions
5. Able to understand and follow study personnel instructions during audiological measurements
6. Native speaker in the language used to assess clinical speech perception performance

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cochlear Implant Recipients	Device: Cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech recognition in quiet	Speech recognition scores in quiet	Testing over 12 months
Speech recognition in noise	Speech recognition scores in noise	Testing over 12 months

Collaborators and Investigators

• Sponsor: The Hearing Cooperative Research Centre
• Collaborators: Cochlear; Attune Hearing; Sydney Cochlear Implant Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 4, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: hearing loss; cochlear implants
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: CLTD 5565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO