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The ReSound® Real Ear Loudness Mapping (RELM) System is substantially equivalent to currently marketed audiometric diagnostic testing equipment and hearing aid analysis systems such as: the ReSound® Portable Prescriptive Programming (P) System and the Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer". The software for the system is substantially equivalent to the ReSound® ReSource™ software that runs under the Noah" operating system.

The RELM test equipment is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone. Similar to the Loudness Growth in Octave Bands (LGOB) Test provided with the ReSound® P System, this new hearing device fitting method is designed to measure loudness growth in hearing-impaired subjects in sound field, instead of with insert phones, in the unaided and aided conditions, through the use of subjective and objective measures, thus integrating both electroacoustic and psychoacoustic test capabilities.

The ReSound® Real Ear Loudness Mapping (RELM) System is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone. This system measures loudness growth in hearing-impaired subjects in sound field, in the unaided and aided conditions, through the use of subjective and objective measures. It integrates both electroacoustic and psychoacoustic test capabilities. The system produces computer generated stimuli delivered via speakers, measures the intensity of the signals via a probe microphone in the patient's ear canal, and displays the values in the form of frequency intensity curves on the PC screen. It also incorporates the patient subjective response data in the calculation of target response curves for determining the hearing device fitting parameters.

The provided text is a 510(k) Premarket Notification for the ReSound® Real Ear Loudness Mapping (RELM) System. It describes the device and claims substantial equivalence to existing devices. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document focuses on:

• Description of the RELM System: Proprietary PC software, sound field speaker system, real ear probe microphone, integrating electroacoustic and psychoacoustic test capabilities.
• Functionality: Measures loudness growth in hearing-impaired subjects in sound field (unaided and aided conditions) using subjective and objective measures. It incorporates patient subjective response data for calculating target response curves and fine-tuning hearing device parameters.
• Claim of Substantial Equivalence: To existing audiometric diagnostic testing equipment and hearing aid analysis systems (ReSound® Portable Prescriptive Programming (P) System and the Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer) and software (ReSound® ReSource™). This equivalence is based on similar functionalities like generating stimuli, measuring signal intensity, and displaying frequency intensity curves, with the RELM system adding patient subjective response incorporation.
• Safety and Effectiveness: States that its use does not significantly affect the safety or effectiveness of currently marketed ReSound® Personal Hearing Systems.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided text.

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