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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus CI532 cochlear implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus CI532 cochlear implant | Device | Retrospective study of the commercial CI532 cochlear implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a commercial CI532 and for which clinical routine hearing measures data are available in their medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Bart Volckaerts, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23348845 | Background | 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. | |
| 15148179 | Background | Dowell 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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162 participants were recruited in five German centres from March 2017 to August 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Nucleus CI532 Cochlear Implant | Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
159 participants were analyzed (two protocol deviations and one participant asked to be withdrawn retrospectively)
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| ID | Title | Description |
|---|---|---|
| BG000 | Nucleus CI532 Cochlear Implant | Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 49 participants with routine speech understanding data available at pre-op and 6 months were analysed. | Posted | Mean | Standard Deviation | Percent correct | pre-operatively and at 6 months post-operatively |
|
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Death, serious adverse events and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nucleus CI532 Cochlear Implant | Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Neben | Cochlear | +4951154277220 | nneben@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2018 | Sep 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2016 | Sep 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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. | 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. | 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. | Pre-operatively and at 6 months post-operatively |
| Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik |
| Erlangen |
| Bavaria |
| 91054 |
| Germany |
| Klinikum der J. W. Goethe-Universität Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Deutsches HörZentrum Hannover der HNO-Klinik der MHH | Hanover | Lower Saxony | 30625 | Germany |
| : Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie | Kiel | Schleswig-Holstein | 24105 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Nucleus CI532 Cochlear Implant |
Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant |
|
|
| Primary | 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. | 15 participants with routine speech understanding data in noise available at pre-op and at 6 months were analyzed. | Posted | Mean | Standard Deviation | Speech Recognition Threshold in decibels | pre-operatively and at 6 months post-operatively |
|
|
|
| Primary | 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. | 99 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare. | Posted | Number | 95% Confidence Interval | Percentage of participants | pre-operatively and at 6 months post-operatively |
|
|
|
| Primary | 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. | 60 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare. | Posted | Number | 95% Confidence Interval | Percentage of participants | Pre-operatively and at 6 months post-operatively |
|
|
|
| Primary | 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. | 36 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare. | Posted | Number | 95% Confidence Interval | Percentage of participants | Pre-operatively and at 6 months post-operatively |
|
|
|
| Primary | 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. | 4 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare. | Posted | Number | 95% Confidence Interval | Percentage of participants | Pre-operatively and at 6 months post-operatively |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Investigators will be able to publish and/or present their own data. The publishing investigator will provide the sponsor with a manuscript copy of the abstract and paper at least 30 days in advance of publication or presentation. If the publication contains information that the sponsor at his discretion finds worth protecting in the form of a patent or trademark etc., the sponsor has the right to delay the publication or presentation for 90 days.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |