Clinical trial NCT03039283: Retrospective CI532 Hearing Performance
Official title: Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: Moderate to profound sensorineural hearing loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).
timeFrame: pre-operatively and at 6 months post-operatively
measure: Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions).
timeFrame: pre-operatively and at 6 months post-operatively
measure: Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.
timeFrame: pre-operatively and at 6 months post-operatively
measure: Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet
timeFrame: Pre-operatively and at 6 months post-operatively
measure: Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.
timeFrame: Pre-operatively and at 6 months post-operatively
measure: Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.
timeFrame: Pre-operatively and at 6 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik
state: Bavaria
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität Frankfurt
state: Hesse
city: Hannover
country: Germany
facility: Deutsches HörZentrum Hannover der HNO-Klinik der MHH
state: Lower Saxony
city: Kiel
country: Germany
facility: : Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
state: Schleswig-Holstein
Study officials:
affiliation: Cochlear
name: Bart Volckaerts, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.