Quality and Compliance

Quality

In pursuit of our belief that everyone on the planet deserves good hearing health, and our commitment to customer satisfaction, product quality and regulatory compliance, SHOEBOX maintains an ISO 13485 quality management system certified by BSI.

Regulatory Registrations

SHOEBOX Audiometry currently maintains the following medical device registrations:

  • Listed as a Class II medical device with US FDA
  • Licensed as a Class II medical device with Health Canada
  • CE marked Class IIa in Europe under the Medical Device Directive (98/42/EEC), notified body BSI Netherlands (2797)
  • Listed as a Class IIa medical device with Australian TGA and New Zealand WAND

Audiometry Standard Compliance

SHOEBOX Audiometry complies with the following product standards:

  • ANSI/ASA S3.6-2018 and IEC 60645-1:2017, Type 3 Audiometer
  • Algorithms comply with ISO 8253:2010 Part 1: Pure-tone air and bone conduction audiometry
  • Calibrations comply with ANSI/ASA S3.6-2018 and IEC 60645-1:2017

Other Compliance

  • SHOEBOX enables employers to comply with their obligations under OSHA and MSHA requirements as required by 21 CFR part 1910.95  as those obligations relate to the customer’s use of SHOEBOX Audiometry Download our 1910.95 summary here
  • SHOEBOX enables customers to comply with their obligations under FRA, CSA, and other local regulations as part of their hearing conservation programs as those obligations relate to the customer’s use of SHOEBOX Audiometry
  • SHOEBOX enables our customers to comply with their obligations under GDPR, HIPAA, PIPEDA and other privacy regulations as those obligations relate to the customer’s use of SHOEBOX Audiometry

Accreditation

  • Health Canada
  • HIPAA
  • ANSI
  • ISO 13485
  • CE