(50 days)
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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MAR - 7 1996
510(k) Premarket Notification - Real Ear Loudness Mapping (RELM)
EXHIBIT E
Summary of Safety and Effectiveness
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.
Substantial equivalence of this analysis system to currently marketed real ear systems as mentioned above is based on the following: (1) this system produces computer generated stimuli delivered via speakers; (2) measures the intensity of the signals via a probe microphone in the patient's ear canal, and; (3) displays the values in the form of frequency intensity curves on the PC screen. The RELM system goes one step further from a real ear analysis system by incorporating the patient subjective response data in the calculation of target response curves for determining the hearing device fitting parameters. This aspect of the system is substantially equivalent to the functions of the ReSound® P' System that calculates hearing device fitting parameters by incorporating LGOB patient test data with the patient's audiometric data and programs the hearing device. As the RELM System monitors the aided sound pressure levels in the ear canal via the probe microphone, the hearing device fitting parameters may be "finetuned" to the patient's loudness target response.
The use of the ReSound® RELM System does not significantly affect the safety or effectiveness of the currently marketed ReSound® Personal Hearing Systems.
1 ReSound® Portable Prescriptive Programming (P) System, 510(k) No. K912669, September 16, 1991
4 Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer, 510(k) No. K872242, July 10, 1987
3 ReSound® ReSource™, 510(k) No. K945750, March 7, 1995
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4 HI-Pro/Noah, 510(k) No. K942749, July 18, 1994
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.