In pursuit of our belief that everyone on the planet deserves good hearing health, and our commitment to customer satisfaction and product quality, Clearwater Clinical maintains an ISO 13485 quality management system certified by the British Standards Institute.
- is a Type 3 Screening Audiometer per ANSI/ASA S3.6-2010 and IEC 60645-1-2017
- algorithms comply with ISO 8253 Part 1: Pure-tone audiometry and bone conduction audiometry
- enables customers to comply with OSHA, MSHA, FRA, CSA, and other local regulations as part of their hearing conservation programs
- enables customers to comply with GDPR, HIPAA, PIPEDA and other privacy regulations,
- is listed as a Class 2 medical device with Health Canada and the FDA,
- is CE marked in Europe under the Medical Device Directive (98/42/EEC).