Paper Contents
Abstract
Hearing aid devices have advanced from basic sound amplifiers to sophisticated technologies featuring digital processing, wireless connectivity, and personalized fitting. This evolution has driven the establishment of robust regulatory frameworks to balance innovation with patient safety. This article describes the device classification, premarket evaluation, labelling, and post-market surveillance. Globally, hearing aids are classified as medical devices under risk-based categories, with labelling standards ensuring clarity, safe use, and patient awareness. Historically, regulation shifted from physician-prescribed models to the introduction of over-the-counter (OTC) hearing aids, enhancing accessibility while upholding safety. Post-market surveillance and adverse event reporting remain central to monitoring performance and guiding updates.
Copyright
Copyright © 2025 Kuppireddy Gowthami Priyanka, kunchala Murali Manohar Joshi, Dr. Ponnada V. Naga Lakshmi, G. Snehalatha. This is an open access article distributed under the Creative Commons Attribution License.
