Sectie 2 van het CIP
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Section 2.2 van het CIP
Secondary outcome
Section 2.2 van het CIP
Background summary
Sectie 1 van het CIP
Study objective
Sectie 2 van het CIP
Study design
Sectie 2 van het CIP
Study burden and risks
There might be minimal additional word and sentence testing performed.
Burden has been reduced to an ablolute minimum
In Section 3 of the CIP risks are described in detail.
Laubisrütistrasse 28
8712 Stäfa
CH
Laubisrütistrasse 28
8712 Stäfa
CH
Listed location countries
Age
Inclusion criteria
* * 18 years of age
* Postlingual onset of severe-to-profound hearing loss (* 4 years of age)
* Sensorineural hearing loss of severe or greater degree in both ears, defined as a pure-tone average (PTA: 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz) of * 70 dB HL
* Marginal hearing aid benefit with appropriately fitted hearing aids, defined as a monosyllabic word score in quiet of * 50% in the best-aided condition
* Proficient in the local language of the investigational center
* Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion criteria
* Cochlear malformation or obstruction that would preclude adequate insertion of electrode array
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or to participate in the study related procedures
* Evidence of central auditory lesion or compromised auditory nerve
* Pregnancy at time of surgery (responsibility of the hospital)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | BFARM, EudraCT: 2011-002572-16 |
CCMO | NL37209.058.11 |