Retrospective CI532 Hearing Performance

NCT03039283 | Completed Results

• 1 other identifier: CEL5661
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 5

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.

Conditions

Hearing Loss

Keywords

Moderate to profound sensorineural hearing loss

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Study Arms (1)

Nucleus CI532 cochlear implant

Device: Nucleus CI532 cochlear implant

Interventions

Nucleus CI532 cochlear implant DEVICE

Retrospective study of the commercial CI532 cochlear implant

Nucleus CI532 cochlear implant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Recipients that have participated in the CLTD5446 study.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (5)

Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik

Erlangen, Bavaria, 91054, Germany

Location

Klinikum der J. W. Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Deutsches HörZentrum Hannover der HNO-Klinik der MHH

Hanover, Lower Saxony, 30625, Germany

Location

: Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (2)

• 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.

  PMID: 23348845 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.

  PMID: 15148179 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Neben
• Organization: Cochlear

nneben@cochlear.com

+4951154277220

Study Officials

• Bart Volckaerts, PhD

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: March 14, 2017
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-07

Locations

DE (5)