Disclaimer

Effective Date: [Insert Date]

1. Medical Disclaimer

  • The products sold by Acevion by Maleous (including OTC hearing aids, hearing amplifiers, bed alarms, ear cleaning devices, and related accessories) are not intended to diagnose, treat, cure, or prevent any disease or medical condition.
  • Our hearing aids and amplifiers are classified as Over-The-Counter (OTC) hearing devices compliant with applicable FDA regulations, designed to improve hearing for individuals with perceived mild to moderate hearing loss.
  • They are not a substitute for professional medical advice, diagnosis, or treatment. If you experience persistent hearing loss, ear pain, or other symptoms, please consult a licensed healthcare professional.

2. Usage Instructions and Risks

  • Use the products strictly according to the provided user manual and safety instructions.
  • Improper use may result in discomfort, hearing damage, or device malfunction.
  • Do not use the devices in hazardous environments (e.g., explosive atmospheres).
  • Keep devices out of reach of children and pets.

3. FDA Compliance and Regulation

  • Our OTC hearing devices comply with the FDA’s OTC Hearing Aid regulations and labeling requirements.
  • The hearing amplifiers and other health accessories comply with relevant consumer product safety standards but are not medical devices and thus are not subject to the same FDA medical device regulations.

4. No Warranty of Results

  • Individual results may vary based on user condition and adherence to usage guidelines.
  • Acevion by Maleous does not guarantee specific hearing improvement or health outcomes.
  • Use at your own risk.

5. Limitation of Liability

  • To the maximum extent permitted by law, Acevion by Maleous shall not be liable for any direct, indirect, incidental, consequential, or punitive damages arising from the use or inability to use our products.
  • This disclaimer applies even if we have been advised of the possibility of such damages.

6. Product Modifications

  • Any unauthorized modification or repair of the products voids all warranties and liabilities.
  • Use only authorized accessories and replacement parts.

7. Contact Information

For questions or concerns about our products or policies, please contact:
📧 support@acevion.com