Hearing LossNCT03039283
Retrospective CI532 Hearing Performance
An observational study of Hearing Loss, run by Cochlear at 5 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Nucleus CI532 cochlear implant
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 5 sitesGermany
- Study dates
- 14 Mar 2017to 28 Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with a commercial CI532 and for which clinical routine hearing measures data are available in their medical records.
Who may be able to join
- 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.
Who cannot join
- Recipients that have participated in the CLTD5446 study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik
Erlangen, Bavaria, 91054
Klinikum der J. W. Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Hanover, Lower Saxony, 30625
: Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Kiel, Schleswig-Holstein, 24105
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Nucleus CI532 cochlear implant
- Keywords
- Moderate to profound sensorineural hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus CI532 cochlear implantDevice
Retrospective study of the commercial CI532 cochlear implant
| Study group | Role | What they receive |
|---|---|---|
| Nucleus CI532 cochlear implant | Not described Receives: Device: Nucleus CI532 cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).
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.
Measured: 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).
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.
Measured: pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.
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.
Measured: pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet
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.
Measured: Pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.
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.
Measured: Pre-operatively and at 6 months post-operatively
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.
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.
Measured: Pre-operatively and at 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start14 Mar 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, PhD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039283
- Sponsor's protocol ID
- CEL5661
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2017
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, Gotter BD, Vanderhoof SS, Mispagel K, Heydebrand G, Skinner MW. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013 May-Jun;34(3):342-60. doi: 10.1097/AUD.0b013e3182741aa7.
PubMed 23348845Dowell RC, Hollow R, Winton E. Outcomes for cochlear implant users with significant residual hearing: implications for selection criteria in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):575-81. doi: 10.1001/archotol.130.5.575.
PubMed 15148179
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients
- ClinicalTrials.gov ID
- NCT03039283
- Acronym / sponsor ID
- CEL5661
- Conditions
- Hearing Loss
- Keywords
- Moderate to profound sensorineural hearing loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nucleus CI532 cochlear implant | – | Device: Nucleus CI532 cochlear implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with a commercial CI532 and for which clinical routine hearing measures data are available in their medical records.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Recipients that have participated in the CLTD5446 study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nucleus CI532 cochlear implantRetrospective study of the commercial CI532 cochlear implant | Device | Nucleus CI532 cochlear implant |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23348845Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, Gotter BD, Vanderhoof SS, Mispagel K, Heydebrand G, Skinner MW. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013 May-Jun;34(3):342-60. doi: 10.1097/AUD.0b013e3182741aa7.
- Background: PubMed 15148179Dowell RC, Hollow R, Winton E. Outcomes for cochlear implant users with significant residual hearing: implications for selection criteria in children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):575-81. doi: 10.1001/archotol.130.5.575.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Volckaerts, PhD study director
Cochlear
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Cochlear at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039283, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.