Hearing Loss
Conditions
Keywords
Moderate to profound sensorineural hearing loss
Brief 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.
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.
Interventions
Retrospective study of the commercial CI532 cochlear implant
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions). | 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). | 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. | 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 | 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. | 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. | 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. |
Countries
Germany
Participant flow
Recruitment details
162 participants were recruited in five German centres from March 2017 to August 2018
Participants by arm
| Arm | Count |
|---|---|
| Nucleus CI532 Cochlear Implant Nucleus CI532 cochlear implant: Retrospective study of the commercial CI532 cochlear implant | 159 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Nucleus CI532 Cochlear Implant | — |
|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 18 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 159 Participants | — |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 86 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: pre-operatively and at 6 months post-operatively
Population: 15 participants with routine speech understanding data in noise available at pre-op and at 6 months were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nucleus CI532 Cochlear Implant | Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions). | -5.5 Speech Recognition Threshold in decibels | Standard Deviation 11.2 |
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.
Time frame: pre-operatively and at 6 months post-operatively
Population: 49 participants with routine speech understanding data available at pre-op and 6 months were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nucleus CI532 Cochlear Implant | Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions). | 26.1 Percent correct | Standard Deviation 26.7 |
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.
Time frame: Pre-operatively and at 6 months post-operatively
Population: 4 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise. | 75 Percentage of participants |
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.
Time frame: Pre-operatively and at 6 months post-operatively
Population: 60 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet | 73.3 Percentage of participants |
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.
Time frame: Pre-operatively and at 6 months post-operatively
Population: 36 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise. | 67 Percentage of participants |
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.
Time frame: pre-operatively and at 6 months post-operatively
Population: 99 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet. | 96 Percentage of participants |