Retrospective CI532 Hearing Performance

October 18, 2019 updated by: Cochlear

Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients

The aim of this retrospective study is to collect and assess hearing performance data that have been measured by five clinics in Germany as part of their clinical routine in recipients implanted with a commercial CI532.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Speech understanding data in quiet and in noise and aided and unaided thresholds, medical history, anomalies in terms of electrode placement are collected through an eCRF. Recipient's device characteristics are collected through cdx files. Surgeon handling and usability of CI532 are collected through paper questionnaire.

The retrospective study is aimed at collection of data for CI532 recipients who have routine hearing measures at pre-implant and post-implant intervals in their medical records.

Patients are approached for study participation by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
        • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Klinikum der J. W. Goethe-Universität Frankfurt
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Deutsches HörZentrum Hannover der HNO-Klinik der MHH
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • : Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with a commercial CI532 and for which clinical routine hearing measures data are available in their medical records.

Description

Inclusion Criteria:

  • Ability to conduct adult hearing performance test material
  • Good German language skills to assess clinical hearing performance
  • CI532 recipients assessed via routine clinical measurements at pre implant, and post implant intervals with available data records in hospital files.
  • Patients that have read, understood and signed the patient informed consent.

Exclusion Criteria:

  • Recipients that have participated in the CLTD5446 study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nucleus CI532 cochlear implant
Device: Nucleus CI532 cochlear implant
Retrospective study of the commercial CI532 cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).
Time Frame: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
pre-operatively and at 6 months post-operatively
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions).
Time Frame: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. An adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.
Time Frame: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet
Time Frame: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
Pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.
Time Frame: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
Pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.
Time Frame: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
Pre-operatively and at 6 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Bart Volckaerts, PhD, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2017

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

August 28, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL5661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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