Directional Microphone Systems for Bimodal Listeners

Completed

• Conditions: 10019243; deafness; profound sensorineurinal hearing loss

• Registration Number: NL-OMON43822
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-11-04
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Bimodal group:
In order to be eligible to participate in the bimodal group of this study, a subject must meet all of the following criteria:
* capacitated adult (>18 years of age)
* patient of CI-team South-East Netherlands
* user of a unilateral cochlear implant (CI) of the brand Advanced Bionics (AB)
* first fit CI ><= 6 months ago
* wearing CI speech processor (almost) always (i.e. circa 10 hours a day)
* wearing a contralateral hearing aid >50% of the time (i.e. circa 5 hours a day)
* able to perform the speech-in-noise test (i.e. speech recognition in quiet >50%)
* willing and able to visit the azM and participate in testing
* agreed to participate in this study (by informed consent);Bilateral group:
In order to be eligible to participate in the bilateral group of this study, a subject must meet all of the following criteria:
* Capacitated adult (>18 years of age)
* Patient of CI-team azM, RadboudUMC or UMCU
* Former subject in the study *Bilateral Cochlear Implantation Benefits in Adult Users of the HiRes(R)
* 90K Bionic Ear System* (NL24660.018.08/NTR1722) who completed the full follow-up period of four years since the first implantation
* User of bilateral cochlear implants (CI*s) of the brand Advanced Bionics (AB)
* First fit of second CI *<= 6 months ago
* Wearing CI speech processor in both ears (almost) always (i.e. circa 10 hours a day)
* Able to perform speech-in-noise test (i.e. speech recognition in quiet with bilateral CI >50%)
* Willing and able to visit the azM and participate in testing
* Agreed to participate in this study (by informed consent);And additionally in the case of a patient of CI-team UMCU or RadboudUMC:
* Agreed to let the research team of the current study inform the own CI-team respectively of his/her participation in the current study (by informed consent)
* Agreed to let the research team of the current study retrieve his/her basic audiological information from the CI-team UMCU or RadboudUMC (by informed consent)

Exclusion Criteria

Bimodal group:
A potential subject who meets any of the following criteria will be excluded from participation in the bimodal group:
* non fluent in Dutch
* < 18 years of age or incapacitated
* bilateral cochlear implant user (CI+CI) ;Bilateral group:
A potential subject who meets any of the following criteria will be excluded from participation in the bilateral group:
* non fluent in Dutch
* < 18 years of age or incapacitated

Study & Design

• Study Type: Interventional
• Study Design: Not specified