68 69Charging accessories: Please note,contraindications are not derived from thecharging accessories, but from the compatiblehearing aids.Intended Patient PopulationHearing aid: This device is intended forpatients from 3 years of age who fulfill theclinical indication for this product. The tinnitussoftware feature is intended for patients from18 years of age who fulfil the clinical indicationfor this feature.Charging accessories: The intended populationis the user of the compatible hearing aids.The primary criteria for the referral of a patientfor a medical or other specialist opinion and /or treatment are as follows:• Visible congenital or traumatic deformityof the ear;• History of active drainage from the ear inthe previous90 days;• History of sudden or rapidly progressivehearing loss in one or both ears withinthe previous 90 days;• Acute or chronic dizziness;• Audiometric air-bone gap equal to orgreater than 15 dB at 500 Hz, 1000 Hzand 2000 Hz;Visible evidence of significant cerumenaccumulation or a foreign body in the earcanal;• Pain or discomfort in the ear;• Abnormal appearance of the eardrumand ear canal such as:• Inflammation of the external auditorycanal• Perforated eardrum• Other abnormalities which the hearingcare professional believes are of medicalconcern