RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM

K960229 · Resound Corp. · ETW · Mar 7, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960229
• Device Name: RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
• Applicant: Resound Corp.
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3310
• Device Class: Class 2

Intended 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.

Device Story

System measures loudness growth in hearing-impaired subjects; utilizes sound field speaker system and real ear probe microphone; inputs include subjective patient responses and objective sound pressure level measurements in ear canal; PC software processes data to generate frequency intensity curves; integrates electroacoustic and psychoacoustic testing; calculates target response curves for hearing device fitting; enables fine-tuning of hearing device parameters to patient loudness targets; used in clinical settings by hearing healthcare professionals; output displayed on PC screen; assists clinicians in optimizing hearing aid performance.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparison of functional capabilities, measurement methods, and data processing logic against predicate audiometric diagnostic and hearing aid analysis systems.

Technological Characteristics

System components: proprietary PC software, sound field speaker system, real ear probe microphone. Operates via PC-based signal generation and data acquisition. Displays frequency intensity curves. Software runs under Noah operating system. No specific material standards or sterilization methods cited.

Indications for Use

Indicated for hearing-impaired subjects requiring hearing device fitting and fine-tuning of hearing device parameters based on loudness growth measurements.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ReSound® Portable Prescriptive Programming (P³) System (K912669)
• Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer (K872242)

Reference Devices

• ReSound® ReSource™ (K945750)
• HI-Pro/Noah (K942749)

Submission Summary (Full Text)

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K940229

RESOUND®

HEARING HEALTH CARE

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 (P³) System¹ and the Frye Electronics, Inc., Type 6400 Real Ear Hearing Aid Analyzer². The software for the system is substantially equivalent to the ReSound® ReSource™ software³ that runs under the Noah⁴ 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® P³ 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® P³ 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 “fine-tuned” 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 (P³) System, 510(k) No. K912669, September 16, 1991
² 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
⁴ HI-Pro/Noah, 510(k) No. K942749, July 18, 1994