Outcome Prediction in 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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The HEARing CRC

Melbourne, Victoria, 3010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cochlear Implant

Device

Primary outcomes

Speech recognition in quiet

Time frame: Testing over 12 months

Speech recognition scores in quiet
Speech recognition in noise

Time frame: Testing over 12 months

Speech recognition scores in noise

Sponsors and collaborators

Lead sponsor

The Hearing Cooperative Research Centre

Other

Collaborators

Attune Hearing
Cochlear
Sydney Cochlear Implant Clinic

Registry information

Official study title

Prediction of Outcomes in Adult Cochlear Implant Recipients

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2020
First posted: Dec 7, 2016
Registry last updated: Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed