Table 2 Exclusion criteria of the PROHEARING clinical trial

1.

Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and tests including imaging (e.g., digital volume tomography, DVT)

2.

Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and tests including imaging (e.g., DVT)

3.

Medical or psychological conditions which contraindicate surgery (e.g., active middle ear infections, tympanic membrane perforation)

4.

Pregnancy or lactation

5.

Additional handicaps that would prevent participation in evaluations

6.

Contraindications for ACEMg:

hepatopathy (transaminases or γ-GT ≥2 x upper limit of normal, ULN)

severe renal insufficiency (serum creatinine >2 x ULN)

disposition to kidney stones

iron-storage disease (thalassemia, hemochromatosis, sideroblastic anemia)

co-medication with vitamin K antagonists

heavy smoking (20 cigarettes per day or more)

7

Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begins