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EFCIM-Trial - Early Fitting after Cochlea Implantation with Prospective Investigation of the Magnet

EFCIM-Trial - Early Fitting after Cochlea Implantation with Prospective Investigation of the Magnet - EFCIM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029683
Enrollment
60
Registered
2022-07-26
Start date
2022-05-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

H91.9

Interventions

Group 1: Early fitting of the Cochlea Implant on the 2nd and 3rd postoperative day
1-, 3-, 6-, 9-, 12-month control Group 2: Regular fitting of the Cochlea Implant 4-6 weeks postoperatively
1-, 3-, 6-, 9-, 12-month control

Sponsors

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, LMU Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients with complication-free cochlea implantation - regular implantation bed - patients above 18 years

Exclusion criteria

Exclusion criteria: - patients with a psychiatric diagnosis - patients with a chronic pain illness - patients with a chronic analgetic medication - patients under 18 years - patients with higher intraoperative bleeding, who required a drainage at the end of the surgical procedure

Design outcomes

Primary

MeasureTime frame
speech perception, magnetic force, complication after CI-surgery at timepoints early fitting/regular first fitting after 4-6 weeks, 3 months, 6 months, 9 months, 12 months

Secondary

MeasureTime frame
magnetic force, complication after CI-surgery at timepoints early fitting/regular first fitting after 4-6 weeks, 3 months, 6 months, 9 months, 12 months, contentness of patient, tinnitus, functional outcome

Countries

Germany

Contacts

Public ContactJennifer Spiegel

Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, LMU Klinikum

jennifer.spiegel@med.uni-muenchen.de00498944000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026