Personalized cochlear implant supply and anatomy-based adaptation of the cochlear implant with Otoplan

Personalized cochlear implant supply and anatomy-based adaptation of the cochlear implant with Otoplan - CharOtoplan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026072

Enrollment

Registered

2021-08-19

Start date

2022-05-02

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

H90.3 H93.1

Interventions

Group 1: A group with individualized CI placement Group 2: A group with conventional CI placement

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: • Patients who, according to the guidelines for cochlear implants of the German Society for Ear, Nose and Throat Medicine, Head and Neck Surgery e. V. have an indication for CI fitting from October 2020 • Residual hearing with a hearing threshold in tone threshold audiometry of <80 dB low tone (500 Hz).

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The primary outcome - the health-related quality of life (NCIQ) - will be measured one week before the implantation, six and twelve months after the cochlear implantation.	—

Secondary

Measure	Time frame
On the first postoperative day, the study group performed a cone-beam CT (resolution 0.08 mm) and the resulting determination of the individual electrode position with OTOPLAN. Four weeks after the operation, as part of the initial setting of the sound processor, pure tone audiometry will be carried out to determine the residual hearing and the anatomical adaptation of the CI based on the postoperative cone-beam CT scan in the study group and standard equipment in the control group. In both patient groups, the frequency allocation to the individual stimulation channels remains unchanged in the further course. In addition, before the implantation, six and twelve months after the cochlear implantation, the “Charité battery” questionnaires will be used to measure: Tinnitus-induced stress (TQ), depressive symptoms (ADS), anxiety-stress level (PSQ), symptoms (GAD7), medical outcomes (Short Form Health 36) and dealing with stress (COPE Inventory). The pure tone audiometry, the Freiburg monosyllabic test in quiet, the Oldenburg sentence test with background noise (OLSA) will be performed before the implantation, six and twelve months after the cochlear implantation.	—

Measure

Time frame

On the first postoperative day, the study group performed a cone-beam CT (resolution 0.08 mm) and the resulting determination of the individual electrode position with OTOPLAN. Four weeks after the operation, as part of the initial setting of the sound processor, pure tone audiometry will be carried out to determine the residual hearing and the anatomical adaptation of the CI based on the postoperative cone-beam CT scan in the study group and standard equipment in the control group. In both patient groups, the frequency allocation to the individual stimulation channels remains unchanged in the further course. In addition, before the implantation, six and twelve months after the cochlear implantation, the “Charité battery” questionnaires will be used to measure: Tinnitus-induced stress (TQ), depressive symptoms (ADS), anxiety-stress level (PSQ), symptoms (GAD7), medical outcomes (Short Form Health 36) and dealing with stress (COPE Inventory). The pure tone audiometry, the Freiburg monosyllabic test in quiet, the Oldenburg sentence test with background noise (OLSA) will be performed before the implantation, six and twelve months after the cochlear implantation.

—

Countries

Germany

Contacts

Public ContactMoritz Gröschel

Charité Campus Virchow-Klinikum

moritz.groeschel@charite.de+49 30 450 555 071

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026