ACAM 5 AUDIOMETER SYSTEM

K103298 · Acousticon GmbH · EWO · Apr 8, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K103298
• Device Name: ACAM 5 AUDIOMETER SYSTEM
• Applicant: Acousticon GmbH
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5 should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.

Device Story

ACAM 5 is a modular audiometer system for clinical diagnosis of hearing loss and hearing aid fitting. Inputs include pure tones, speech signals, and ambient sounds; system utilizes headphones, bone conduction transducers, loudspeakers, and in-situ ear probes. Device performs signal analysis including RMS, FFT, and percentile analysis to support REM, HIT, and loudness scaling. Operated by trained professionals (audiologists, ENT specialists) in clinics. Output is displayed via software, providing diagnostic data and fitting reports to assist clinicians in optimizing hearing aid parameters. Benefits include improved accuracy in hearing aid fitting and diagnostic assessment through standardized protocols (NAL, DSL-IO) and real-life simulation via video sequences.

Clinical Evidence

Bench testing only. Compliance with international consensus standards (EN 60601-1, EN 60601-1-1, EN 60601-1-2) for electrical safety and electromagnetic compatibility, and performance standards (ANSI S3.6, ANSI S3.46, ANSI S3.22) for audiometry and real-ear performance characteristics.

Technological Characteristics

Modular audiometer system; 19" rack form factor. Components: control unit, test boxes, in-situ probes, headphones, loudspeakers. Connectivity: TCP/IP network protocol. Standards: IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43. Electrical safety: EN 60601-1 Class 1, Type B.

Indications for Use

Indicated for patients of any age with demonstrated hearing loss capable of understanding test principles. Used by audiologists, hearing aid dispensers, nurses, and ENT specialists for diagnostic hearing evaluations, hearing aid fitting, and loudness scaling.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Predicate Devices

• Siemens Unity 2 (K# unknown)
• Siemens Unity 2 HIA and Probe (K071462)

Submission Summary (Full Text)

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APR - 8 2011

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# : 510(k) Summary, ACAM 5

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

| Submitted By: | Acousticon GmbH<br>Hirschbachstrasse 48<br>D-64354 Reinheim<br>Germany<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen N. Garner<br>New World Regulatory Solutions, Inc.<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 3, 2011 |
| Proprietary Name: | ACAM® 5 Audiometer System |
| Common Name: | Audiometer |
| Classification Status: | Class II exempt, 21 CFR 874.1050, Audiometer |
| Subsequent, Classifications: | Class II, 21 CFR 874.3310, Hearing Aid Calibrator and<br>Analysis System<br>Class II, 21 CFR 874.1120, Electronic noise generator for<br>audiometric testing |
| Regulation Name: | Audiometer |
| Product Code: | EWO |
| Subsequent Product Codes: | ETW, ETS |

# Predicate Device Information:

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- Siemens Unity 2 (K# unknown) and Siemens Unity 2 HIA and Probe, K071462 .
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### 510(k) SUMMARY, continued

### Device Description

ACAM® 5 is an audiometer with optional components for performing Real Ear Measurements (REM) Hearing Instrument Testing (HIT) and loudness scaling. It is intended to aid trained audiologists and hearing aid professionals in the diagnosis of hearing loss and the fitting of hearing aids. As a part of the REM and HIT modules ACAM performs several kinds of signal analysis including root mean squared (RMS), fast Fourier transformation (FFT) and percentile analysis (PA). ACAM® 5 gives an audiologist the ability to use one or any combination of the diagnostic tools recommended by the National Acoustics Laboratory (NAL) and Dr. Richard Seewald (DSL-IO).

Available ACAM® 5 hardware consists of an audiometer with a modular control unit for peripheral components, which include a large or small hearing instrument test box and an in sity ear probe for real ear measurement. Headphones for audiometry, bone conduction and loudness scaling. loudspeakers, a microphone and an interrupter switch are available for use with the audiometer.

ACAM®'s operational software meets the international software standards established by the Hearing Instruments Software Manufacturers Association (HIMSA) and the speech recognition standards (ISTS, International Speech Test Signals) established by the-European Hearing Instrument Manufacturers Association (EHIMA).

The ACAM® 5 system meets or exceeds the following international standards: IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43

ACAM® 5 should be operated by individuals with education and training in the field of audiology such as audiologists, hearing aid dispensers, health care and school nurses and ear nose and throat specialists. ·

### Intended Use/Indications for Use

ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM). Hearing Instrument Test (HIT) and loudness scaling. ACAM 5° should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.

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### 510(k) Summary, continued

#### Technological Characteristics

The ACAM® 5 System has substantially the same technological characteristics as the predicate, Siemens Unity 2 audiometer (K# unknown), with the HIA and Probe for use with Unity 2, cleared on June 5, 2007 under K071462.

#### Similarities

Both the Acousticon ACAM® 5 and the Siemens Unity 2 are modular systems intended for the diagnosis of hearing loss and optimization of the acoustical parameters of hearing aid fitting. Both the ACAM® 5 (applicant) and Siemens (predicate) systems provide modular components that can be used individually or in tandem to support processes from hearing aid fitting. Both the predicate and the applicant systems are computer controlled and include software specific for their applications, including links to the NOAH™ software applications provided by the Hearing Instrument Manufacturers' Software Association (HIMSA™). Both the applicant and the predicate systems utilize Real Ear Measurement (REM) fitting protocols that include percentile measurement to analyze the dynamic feature of amplified speech signals. Both the applicant and the predicate systems allow for the use of fitting protocols provided by the National Acoustic Laboratory (NAL-NL1) and by Dr Richard Seewald (DSL-IO). Both the predicate and applicant systems utilize optional visual stimuli that accompany ambient background sounds. Both the predicate and applicant systems offer ambient sound modules to optimize hearing aid performance in real life situations. Both Systems have an audiometer module to measure hearing losses with pure tone and speech following the requirements of ANSI S3.6.

#### Differences

The predicate system uses single tone frequency scaling over a range of 125 - 8,000 Hz (normal mode) and 125 - 16.000 Hz (high frequency mode), using mean background noise levels and a fixed signal to noise ratio (SNR), while the applicant system uses single tone frequency scaling over a range of 125 - 8.000 Hz and does not have a high frequency mode. The predicate system offers ambient sounds accompanied by still pictograms (SPL O gram) of environmental surroundings and two speakers, while the applicant system employs video sequences (real life fitting, or RLF sequence) with up to 12 speakers. The applicant system provides a broader menu of ambient sound selections than the predicate system. The predicate integrated system includes hearing aid programming with a Siemens hearing aid. The applicant does not include hearing aid programming.

#### Comparison to Predicate Device

The ACAM 5 Audiometer is equivalent to the predicate device in intended use its technological characteristics, design and function, as demonstrated in the comparison table below:

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| Device<br>Specifications | Siemens Unity 2, with HIA and Probe | | ACAM 5 | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| K Number | K# unknown, K071462 (HIA and Probe) | | K103298 | |
| Intended use | See indications for use | | See indications for use | |
| Indications for use | The Unity 2 is indicated for use in<br>conducting diagnostic hearing<br>evaluations and assisting in the diagnosis<br>of possible otologic disorders. The Unity<br>2 HIA and Probe are intended to be used<br>as a system to: (1) perform Real Ear<br>Measurement; (2) get an objective<br>indication of the characteristics of a<br>hearing aid; and (3) assist in the<br>adjustment of hearing aids while in use<br>by the patient. It is used by ENT<br>professionals and in clinics for hearing<br>aid fitting. This device can either be sold<br>individually or together with other Unity 2<br>modules. | | ACAM 5 is intended as an aid in<br>diagnosing hearing loss and fitting of<br>hearing aids. The device consists of an<br>audiometer that can be used individually<br>or with the other ACAM modules for<br>performing Real Ear Measurements<br>(REM), Hearing Instrument Test (HIT)<br>and loudness scaling. ACAM 5 should<br>be used by persons trained in audiology<br>on patients of any age who are able to<br>understand the basic principles of the<br>test method when explained by the<br>operator. | |
| Target population | Individuals of any age who have<br>demonstrated hearing loss, and who are<br>able to understand and respond to the<br>basic principles of the test method when<br>explained by the operator. | | Individuals of any age who have<br>demonstrated hearing loss, and who are<br>able to understand and respond to the<br>basic principles of the test method when<br>explained by the operator | |
| Anatomical sites | Ear | | Ear | |
| Where used | Clinics and on-site applications | | Clinics and on-site applications | |
| Energy used<br>and/or delivered | Hz | dB HL | Hz | dB HL |
| Air line<br>Headphones | 125 | 100 / 90 | 125 | 90 |
| | 250 | 110 / 110 | 250 | 110 |
| | 500 | 115 / 120 | 500 | 120 |
| | 750 | 120 / 120 | 750 | 120 |
| | 1000 | 120 / 120 | 1000 | 120 |
| | 1500 | 115 / 120 | 1500 | 120 |
| | 2000 | 115 / 120 | 2000 | 120 |
| | 3000 | 115 / 120 | 3000 | 120 |
| | 4000 | 115 / 120 | 4000 | 120 |
| | 6000 | 105 / 120 | 6000 | 120 |
| | 8000 | 110 / 105 | 8000 | 110 |
| | 10000 | / 100 | | |
| | 12500 | / 90 | | |
| | 16000 | / 60 | | |
| Bone line<br>Headphones | 125 | 40 | 125 | 45 |
| | 250 | 50 | 250 | 60 |
| | 500 | 70 | 500 | 70 |
| | 750 | 70 | 750 | 70 |
| | 1000 | 70 | 1000 | 70 |
| | 1500 | 70 | 1500 | 70 |
| | 2000 | 70 | 2000 | 75 |
| | 3000 | 70 | 3000 | 80 |
| | 4000 | 60 | 4000 | 80 |
| | 6000 | 60 | 6000 | 60 |
| Table of Similarities and Differences, continued | | | | |
| Device<br>Specifications | Siemens Unity 2 with HIA and Probe | | ACAM 5 | |
| Energy used<br>and/or delivered | Hz | dB HL | Hz | dB HL |
| Air Line Speakers | 125<br>250<br>500<br>750<br>1000<br>1500<br>2000<br>3000<br>4000<br>6000<br>8000 | 80<br>90<br>90<br>90<br>90<br>90<br>90<br>90<br>90<br>80<br>65 | 125<br>250<br>500<br>750<br>1000<br>1500<br>2000<br>3000<br>4000<br>6000<br>8000 | 68<br>85<br>95<br>95<br>95<br>95<br>95<br>100<br>100<br>95<br>75 |
| Human factors | Subjective loudness response | | Subjective loudness response | |
| Design | Modular components consisting of:<br>Audiometer and headphones, external<br>speakers, hearing instrument test box<br>and microphone, software | | Modular components consisting of:<br>Audiometer and headphones, external<br>speakers, hearing instrument test box<br>and microphone, software | |
| Testing Features | • Real Ear measurement<br>• Pure tone and speech audiometry<br>• Loudness scaling and noise impulse<br>audiometry<br>• ISTS. International Speech Test<br>Signal<br>• Pediatric audiometry, if requested<br>• Automated fitting report<br>• Percentile analysis | | • Real Ear measurement<br>• Pure tone and speech audiometry<br>• Loudness scaling and noise impulse<br>audiometry<br>• ISTS. International Speech Test<br>Signal<br>• Pediatric audiometry, if requested<br>• Automated fitting report<br>• Percentile Analysis | |
| Available Tests | Audiometer:<br>• Air conduction<br>• Bone conduction<br>• Free field (10 W integrated 2-channel<br>amplifier) | | Audiometer:<br>• Air conduction<br>• Bone conduction<br>• Free field 4 Channel Standard<br>(optional up to 12 Channel) with 20W<br>Power | |
| Tests conducted<br>above hearing<br>threshold | • SISI test<br>• ABLB test (Fowler)<br>• DLI test (Luescher)<br>• Stenger test<br>• Tone decay test (Carhart) | | • ABLB test (Fowler)<br>• Stenger test<br>• Tone decay test (Carhart)<br>• Speech Audiometry in quiet and in<br>Noise<br>• ANL(acceptable Noise Level) | |
| Tests conducted<br>above hearing<br>threshold | • SISI test<br>• ABLB test (Fowler)<br>• DLI test (Luescher)<br>• Stenger test<br>• Tone decay test (Carhart) | | • ABLB test (Fowler)<br>• Stenger test<br>• Tone decay test (Carhart)<br>• Speech Audiometry in quiet and in<br>Noise<br>• ANL (acceptable Noise Level) | |

# Table of Similarities and Differences

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# Table of Similarities and Differences, continued

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| Device<br>Specifications | Siemens Unity 2 with HIA and Probe | ACAM 5 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional Tests<br>Offered | • REUR (Real Ear Unaided Response),<br>• OEG (Open Ear Gain)<br>• REOR (Real Ear Occluded Response)<br>• REAR (Real Ear Aided Response,<br>SPL level at the eardrum) | • REUR (Real Ear Unaided Response),<br>• OEG (Open Ear Gain)<br>• REAR (Real Ear Aided Response,<br>SPL level at the eardrum) |
| | • REIG (Real Ear Insertion Gain)<br>• RECD (Real Ear-to-Coupler<br>Difference)<br>• LI/LO (Input-/Output curve)<br>• Sound Mapping<br>• On top mode<br>• Percentile analysis | • REIG (Real Ear Insertion Gain)<br>• RECD (Real Ear-to-Coupler<br>Difference)<br>• LI/LO (Input-/Output curve)<br>• Percentile analysis |
| Technical<br>specifications | Common Data for all Applications:<br>• Frequency Accuracy: ± 1 %<br>• FFT: Resolution 1024 points,<br>Averaging: 10-100<br>• Intensity Accuracy: ± 1.5 dB<br>• Sweep Speed: 1.5 - 12 sec./decade at<br>25 Hz warble frequency (depending<br>on frequency resolution)<br>• Frequency Resolution: 1/3, 1/6, 1/12<br>and 1/24 octave<br>• Stimulus Distortion: Less than 1 %<br>THD | Common Data for all Applications:<br>• Frequency Accuracy: < 1 %<br>• FFT: Resolution 2048 points,<br>Averaging: 10-100<br>• Intensity Accuracy: ± 1.5 dB<br>• Sweep Speed: 1.5 - 12 sec./decade at<br>25 Hz warble frequency (depending<br>on frequency resolution)<br>• Frequency Resolution: up to 2048<br>points between 100Hz and 10kHz<br>• Stimulus Distortion: Less than 1 %<br>THD |
| Frequency Range | • 125 Hz - 8 kHz (AC & free field)<br>• 125 Hz - 16 kHz (AC, HF mode)<br>• 250 Hz - 6 kHz (BC) | • 125 Hz - 8 kHz (AC & free field)<br>• No HF mode<br>• 125 Hz - 8 kHz (BC) |
| Stimulus-Signal | • Pure tone, warble,<br>• Noise signals: White, narrow band,<br>speech<br>• ILTASS | • Pure tone, warble,<br>• Noise signals: White, narrow band,<br>speech |
| Measurement<br>Intensity Range | • AC: -10 - 130 dB HL<br>• BC: -10 - 80 dB HL | • AC: -10 - 120 dB HL<br>• BC: -10 - 70 dB HL |
| Frequency Range | • 125 Hz - 8 kHz (AC & free field)<br>• 125 Hz - 16 kHz (AC, HF mode)<br>• 250 Hz - 6 kHz (BC) | Audiometry<br>• 125 Hz - 8 kHz (AC, BC & free field)<br>HIT & REM<br>• 100 Hz - 10 kHz |
| Target gain<br>formulas | NAL-NL1 and DSL i/o; NAL-RP, Berger,<br>Pogo II, 1/3 Gain, 1/2 Gain, Fig6 (K-AMp) | NAL-NL1, DSL i/o, DSL mio; NAL-RP,<br>Berger, Pogo II, 1/3 Gain, 1/2 Gain, Fig6<br>(K-AMP), IDM, own Rules |
| Stimulus-Signal: | • Pure tone, warble,<br>• Noise signals: Narrow band, White,<br>Pink, Speech, ILTASS, ICRA, Chirp,<br>patient voice | • Pure tone, warble, CHIRP, Burst<br>• Noise signals: Narrow band, White,<br>Pink, Speech, ICRA,<br>• Real Signals: Speech, ISTS (about<br>200 live Signals) |
| Test Intensity<br>Range | Adjustable increments of 1 dB<br>• Speaker: 40 - 100 dB SPL | Adjustable increments of 1.dB<br>• Speaker: 0 - 100 dB SPL<br>• Open headphones: 0 - 100 dB SPL<br>• Insertion Earphones: 40 - 140 SPL |
| Device | Siemens Unity 2 with HIA and Probe | ACAM 5 |
| Specifications<br>Measurement | • Microphone: 40 - 145 dB SPL | • Microphone: <30 to >140 dB SPL |
| Intensity Range | | |
| Loudspeaker | • Max. 6 W into 8 ohms | • Max. 20 W into 4 ohms |
| Output | • Max. 10 W into 4 ohms | |
| Hearing Instrument | • Single measurement (configurable): | • Single measurement (configurable): |
| Analyzer | • OSPL90 | • OSPL90 |
| | • Full On Gain | • Full On Gain |
| | • Input/Output | • Input/Output |
| | • Attack/Release Time…