(50 days)
No
The description focuses on electroacoustic and psychoacoustic measurements and data display, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device is described as audiometric diagnostic testing equipment and a hearing aid analysis system designed to measure loudness growth and determine hearing device fitting parameters, not to provide therapy itself.
Yes
The RELM System measures loudness growth in hearing-impaired subjects to determine hearing device fitting parameters, integrating electroacoustic and psychoacoustic test capabilities. This process of measuring and characterizing a physiological or functional state to inform a medical intervention (fitting hearing aids) falls under the definition of a diagnostic device. The text explicitly states it is "substantially equivalent to currently marketed audiometric diagnostic testing equipment".
No
The device description explicitly states that the system is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone, indicating it includes hardware components beyond just software.
Based on the provided text, the ReSound® Real Ear Loudness Mapping (RELM) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RELM System Function: The description clearly states that the RELM system measures loudness growth in hearing-impaired subjects in sound field using a real ear probe microphone placed in the patient's ear canal. It uses subjective and objective measures based on the patient's response to sound and electroacoustic measurements within the ear.
- No Specimen Collection/Analysis: There is no mention of collecting any biological specimens from the patient for analysis. The system interacts directly with the patient's auditory system and their perception of sound.
Therefore, the RELM system falls under the category of diagnostic equipment used for assessing hearing function, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ReSound® Real Ear Loudness Mapping (RELM) System 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.
Product codes
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Device Description
The RELM test equipment is comprised of proprietary PC software, a sound field speaker system, and a real ear probe microphone. This 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. The RELM system incorporates patient subjective response data in the calculation of target response curves for determining the hearing device fitting parameters. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's ear canal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
0:22
4 HI-Pro/Noah, 510(k) No. K942749, July 18, 1994