Retrospective CI532 Hearing Performance

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039283
• Other study ID #: CEL5661
• Status: Completed
• Start date: March 14, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: July 2019
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Nucleus CI532 cochlear implant
Retrospective study of the commercial CI532 cochlear implant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	pre-operatively and at 6 months post-operatively
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.	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.	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.	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.	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.	Pre-operatively and at 6 months post-operatively