Outcome Prediction in Cochlear Implant Recipients

Prediction of Outcomes in Adult Cochlear Implant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02984748

Enrollment

267

Registered

2016-12-07

Start date

2014-10-07

Completion date

2020-12-31

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

cochlear implants, hearing loss

Brief summary

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.

Interventions

DEVICECochlear implant

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026