Hearing preservation in cochlear implantation surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20714

Enrollment

Registered

2020-05-04

Start date

2020-01-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural hearing loss, deafness

Interventions

Round window or cochleostomy insertion approach and either lateral wall or perimodiolar electrode array

Eligibility

Inclusion criteria

Inclusion criteria: - Dutch language proficiency - 18 years or older - Choice for Advanced Bionics implant - Normal function of middle ear (i.e. no acute middle ear infections)

Exclusion criteria

Exclusion criteria: - Prior otologic surgery in the implanted ear (excluding tympanostomy tube placement) - Inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation) - Retrocochlear pathology present in the auditory system to be implanted - Neurocognitive disorders - Sudden deafness

Design outcomes

Primary

Measure	Time frame
Hearing preservation; postoperative pure tone audiometry	—

Secondary

Measure	Time frame
scalar localization on computed tomography (i.e. scala tympani or vestibuli), speech perception, ECochG intra- and postoperative,	—

Contacts

Public ContactSaad Jwair

UMC Utrecht

s.jwair@umcutrecht.nl088 7569476

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)