Food supplement induced residual hearing preservation in partial insertion - cochlear implantatio

Not Applicable

Recruiting

Conditions: Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated
H90
Conductive and sensorineural hearing loss

Registration Number: DRKS00021627

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 148

Inclusion Criteria

2.Intended to receive a hearing or structure preservation cochlear implant

3.Residual hearing less or equal than 85 dB HL at 125 Hz, 90 dB HL at 250 Hz and 95 dB HL at 500 Hz in the ear to be implanted at last routine appointment

4.Ability to understand the study procedures, possible risks and benefits, and to give informed consent.

5.Informed Consent is signed.

6.Patients must agree not to use daily vitamin preparations containing vitamin A, C or E or magnesium during the course of the study, and beginning at least 24 hours prior to first intake of the study medication

Exclusion Criteria

1. Pregnancy or lactation
2. Additional handicaps that would prevent participation in evaluations
3. Pre-existing conditions:
3.1 hepatopathy
3.2 severe renal insufficiency
3.3 disposition to kidney stones
3.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anemia)
3.5 co-medication with vitamin K-antagonists
3.6 heavy smoking (= 10 cigarettes per day)
4. Current participation in any other interventional study and/or participation in another interventional study within 30 days before the study begins

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing loss at the implanted ear at 500 Hz 3 months post First Fitting (hearing loss = 3 months post First Fitting threshold minus 1-2 days pre-operatively threshold) measured by air conducted pure tone audiometry in ACEMg individuals compared to placebo controls.

Secondary Outcome Measures

Name	Time	Method
1. Hearing loss at the implanted ear measured by pure tone audiometry at 500 Hz day 1 of First Fitting and 6 months post First Fitting<br>2. Hearing loss measured by pure tone audiometry for 125 and 250 Hz over time (day 1 of First Fitting, months 3 and 6 post First Fitting)<br>3. Speech perception by OLSA, month 6 after First Fitting<br>4. Impedances at all time points (First Fitting day 1 and day 3, month 3 and month 6 after First Fitting)<br>Safety Endpoints:<br>1) All SAEs<br>2) All AEs <br>