Table 1 Inclusion criteria of the PROHEARING clinical trial

1.

18 years of age or older

2.

No or little benefit from a conventional hearing aid, defined as preoperative auditory speech understanding of less or equal 60 % in Freiburger monosyllables at 65 dB SPL, best aided in the ear to be implanted

3.

Residual hearing better or equal than 85 dB HL at 125, 90 dB HL at 250 Hz and better or equal than 95 dB HL at 500 Hz in the ear to be implanted

4.

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

5.

Informed Consent Document is signed.

6.

Patients must agree not to use daily vitamin preparations containing vitamins A, C or E or magnesium during the course of the study, and beginning at least 48 hours prior to first intake of the study medication

7.

Female patients 50 years of age or older at the day of inclusion who have been postmenopausal for at least 1 year

Or

Female patients who have a negative hCG serum pregnancy test and meet one or more of the following criteria:

are 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy

with or without hysterectomy

are using proven oral, injected or implanted hormonal contraceptive methods:

intrauterine device or intrauterine system

barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam/gel/film/cream/suppository)

male sterilization (if the absence of sperm in the ejaculate is documented. For female participants the vasectomized male partner should be the sole sexual partner for that subject)

true abstinence (periodic abstinence and coitus interruptus are not acceptable methods of contraception)

only female sexual partners