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IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
In the ear aids (ITE) devices fit in the outer ear bowl (called the concha). Being larger, these are easier to insert and can hold extra features. [16] They are sometimes visible when standing face to face with someone. ITE hearing aids are custom made to fit each individual's ear. They can be used in mild to some severe hearing losses.
An earplug is a device that is inserted in the ear canal to protect the user's ears from loud noises, intrusion of water, foreign bodies, dust or excessive wind. Earplugs may be used as well to improve sleep quality or focus in noisy environments.
Real ear measurement is the measurement of sound pressure level in a patient's ear canal developed when a hearing aid is worn. It is measured with the use of a silicone probe tube inserted in the canal connected to a microphone outside the ear and is done to verify that the hearing aid is providing suitable amplification for a patient's hearing loss. [2]
A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls as described below are met. [3] The vast majority of new medical devices (99%) enter the marketplace via this process.
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
Electronic fluency devices (also known as assistive devices, electronic aids, altered auditory feedback devices and altered feedback devices) are electronic devices intended to improve the fluency of persons who stutter. Most electronic fluency devices change the sound of the user's voice in his or her ear.
New age portable digital audiometer. An audiometer is a machine used for evaluating hearing acuity. They usually consist of an embedded hardware unit connected to a pair of headphones and a test subject feedback button, sometimes controlled by a standard PC.
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