to study search History

Influence of Contralateral Routing of Signals (CROS) on Hearing Abilities of Different Groups of Cochlear Implant Users

Organizational Data

DRKS-ID:
DRKS00013973
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-03-16
Last update in DRKS:
2022-11-07
Registration type:
Retrospective

Acronym/abbreviation of the study

ABIntl-17-14

URL of the study

No Entry

Brief summary in lay language

No Entry

Brief summary in scientific language

The use of a CROS-device in unilateral CI-recepients can lead in combination with a CI-device to a better speech understanding in noise in comparision to CI-usage alone. Device Naída CI Q90 sound processor, Naída Link hearing aids and Naída Link CROS Study Design: Within subject comparison Regulatory Objective: Post-market study Study Population: 40 adult CI users and 10 adult normal hearing listeners as reference group Inclusion Criteria • Unilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side • Bimodal group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side and hearing aid contralaterally • Bilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on both sides • Minimum of 18 years of age • Minimum of six months experience with their hearing devices • 65% speech recognition for the OlSa in quiet at 65 dB SPL with CI only (1st side) • German language proficiency • Ability to provide subjective feedback on sound quality and speech understanding Exclusion Criteria • Difficulties additional to hearing impairment that would interfere with the study procedures. Primary Study Objective The primary objective of this study is to compare the speech intelligibility with one CI and the contralateral CROS device to the speech intelligibility with CI and unaided contralateral side in the presence of speech shaped noise. Primary Study Measure Difference in the speech reception threshold (SRT) in the OlSa in presence of speech shaped noise between CI only and CI + CROS, measured in dB SNR. Secondary Study Objective To compare speech intelligibility and localization abilities between CI only and CI + a second hearing instrument (CI, HA or CROS) Secondary Study Measure Difference in speech reception threshold in dB for speech intelligibility and localization error for localization abilities, measured in dB SNR and degree, respectively, between CI only and CI + a second hearing instrument (CI, HA or CROS) Study Schedule December 01, 2017 to November 30, 2018 Study Monitoring Advanced Bionics GmbH, European Research Center Statistical Analysis Co-operation Universitätsklinikum Freiburg and Advanced Bionics

Health condition or problem studied

ICD10:
Z96.2 - Presence of otological and audiological implants
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Bilateral Cochlea Implant User group (N=10) speech intelligibility in quiet and noise, localization abilities, audiograms, subjective feedback via questionnaires
Arm 2:
Unilateral Cochlea Implant user group (N = 10) speech intelligibility in quiet and noise, localization abilities, audiograms, subjective feedback via questionnaires
Arm 3:
Group of patients with cochlea implant on one side and conventional hearing aid on the other side (N=20) speech intelligibility in quiet and noise, localization abilities, audiograms, subjective feedback via questionnaires
Arm 4:
normal hearing group (N=10) speech intelligibility in quiet and noise, localization abilities, audiograms, subjective feedback via questionnaires

Endpoints

Primary outcome:
• Speech intellegibility with CI and contralateral CROS device versus CI and unaided contralateral side • OLSa measurment in dB in noise • unilateral CI recipients
Secondary outcome:
•Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) in terms of differences in speech intelligibility in quiet •Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) as well as different microphone options (omni, UltraZoom, StereoZoom) in terms of differences in speech intelligibility in stationary speech shaped noise •Comparison of different device configurations (CI only, CI + CROS, CI + HA, CI + CI) in terms of differences in localization abilities.

Study Design

Purpose:
Treatment
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2018-03-20
Actual study start date:
2018-02-20
Planned study completion date:
No Entry
Actual Study Completion Date:
2020-11-24
Target Sample Size:
50
Final Sample Size:
51

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
•Unilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side •Bimodal group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on one side and hearing aid contralaterally •Bilateral group: CII, HiRes90K, HiRes90K Advantage or HiRes Ultra implant system on both sides •Minimum of 18 years of age •Minimum of six months experience with their hearing devices •65% speech recognition for the OlSa in quiet at 65 dB SPL with CI only (1st side) •German language proficiency •Ability to provide subjective feedback on sound quality and speech understanding

Exclusion Criteria

• Difficulties additional to hearing impairment that would interfere with the study procedures.

Addresses

Primary Sponsor

Advanced Bionics GmbHEuropean Research Center
Dr. Volkmar Hamacher
Feodor-Lynen-Straße 35
30625 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Advanced Bionics AG
Martina Brendel
Laubisrütistrasse 28
8712 Stäfa
Switzerland
Telephone:
+41 58 928 78 00
Fax:
+41 58 928 78 00
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Advanced Bionics AG
Martina Brendel
Laubisrütistrasse 28
8712 Stäfa
Switzerland
Telephone:
+41 58 928 78 00
Fax:
+41 58 928 78 00
Contact per E-Mail
URL:
No Entry

Principal Investigator

Advanced Bionics AG
Martina Brendel
Laubisrütistrasse 28
8712 Stäfa
Switzerland
Telephone:
+41 58 928 78 00
Fax:
+41 58 928 78 00
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Advanced Bionics GmbHEuropean Research Center
Feodor-Lynen-Straße 35
30625 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-11-28
Ethics committee number:
588/17
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-01-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Studienprotokoll
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry