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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the ACAM 5 Audiometer System based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACAM® 5 Audiometer System are primarily based on compliance with established international and national standards for audiometers and hearing instrument analyzers. The document presents a comparison to a predicate device (Siemens Unity 2 with HIA and Probe) to demonstrate substantial equivalence, rather than a direct performance study with a specific set of acceptance metrics for diagnostic accuracy.

The reported device performance, in terms of meeting these standards, is stated as "in compliance with the requirements of the international consensus standards shown below."

Acceptance Criteria Category	Specific Acceptance Criteria (Standards Met)	Reported Device Performance
Safety	EN 60601-1 1996-03 (Medical electrical equipment: Part 1: General requirements for safety)	Complies with requirements
	EN 60601-1-1:2001 (Medical electrical equipment; Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems)	Complies with requirements
	EN 60601-1-2:2001 (Medical electrical equipment; Part 1: General requirements for safety; Collateral standard: Electromagnetic compatibility - Requirements and tests)	Complies with requirements
Effectiveness	ANSI S3.6-2004 (Specification for Audiometers)	Complies with requirements
	ANSI S3.46-1997(R2007) (Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids)	Complies with requirements
	ANSI S3.22-2003 (Specification of Hearing Aid Characteristics)	Complies with requirements
Additional Standards Met (implicitly part of acceptance of substantial equivalence)	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 (These are listed as standards the ACAM® 5 system meets or exceeds)	Meets or exceeds these standards

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical performance study involving human subjects or a specific test set for evaluation of diagnostic accuracy. The "test set" in this context refers to the rigorous testing against engineering and clinical performance standards.

Sample Size for Test Set: Not applicable in the context of human subject data. The testing involved physical device measurements against specified standard requirements.
Data Provenance: Not applicable for human subject data. The "provenance" of the compliance data comes from internal testing and validation against international and national standards by the manufacturer. The location of the manufacturer (Germany) suggests the testing likely occurred in Germany or by an accredited European testing body. The document states it was subjected to electrical safety and EMC testing and performance specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the sense of expert consensus on patient diagnoses or conditions, is not described as part of this submission. The "ground truth" for the device's technical specifications and performance is the requirements set forth in the various international and national standards. These standards are established by expert bodies in the field of audiology and medical device safety/performance.

4. Adjudication Method for the Test Set

Not applicable. Since there isn't a human-read or AI-interpreted test set with subjective outcomes needing adjudication, this section is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This submission focuses on demonstrating substantial equivalence to a predicate device (Siemens Unity 2) based on technical characteristics and compliance with recognized standards. It is not an AI-assisted diagnostic device, so a study on human readers' improvement with AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "performance test data" discussed are essentially standalone evaluations of the device's adherence to technical standards. The system itself is an audiometer, and its performance (e.g., accuracy of frequency output, intensity output, signal distortion) is evaluated independently against engineering specifications as defined by the standards (e.g., ANSI S3.6-2004 for audiometers). This is not an "algorithm only" in the modern AI sense, but rather a standalone device performance check.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the technical specifications and requirements outlined in recognized international and national standards for audiometers and hearing instrument analyzers. The device's performance parameters (e.g., frequency accuracy, intensity accuracy, stimulus distortion) are compared against the limits and criteria specified in these standards (e.g., IEC 60645, ANSI S3.6, etc.).

8. The Sample Size for the Training Set

Not applicable. This device is an audiometer, not an AI/machine learning algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for this device.

Summary

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APR - 8 2011

: 510(k) Summary, ACAM 5

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

Submitted By:	Acousticon GmbHHirschbachstrasse 48D-64354 ReinheimGermanyTelephone: +49 6162 93240Fax: +49 6162 932449Email: harald.bonsel@acousticon.de
Contact Person:	Maureen N. GarnerNew World Regulatory Solutions, Inc.Telephone: (732) 779 7422Fax: (732) 270 4829Email: NWRSinc@gmail.com
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 andAnalysis SystemClass II, 21 CFR 874.1120, Electronic noise generator foraudiometric testing
Regulation Name:	Audiometer
Product Code:	EWO
Subsequent Product Codes:	ETW, ETS

Predicate Device Information:

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

DC
4//////

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510(k) SUMMARY, continued

Device Description

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

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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DeviceSpecifications	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 inconducting diagnostic hearingevaluations and assisting in the diagnosisof possible otologic disorders. The Unity2 HIA and Probe are intended to be usedas a system to: (1) perform Real EarMeasurement; (2) get an objectiveindication of the characteristics of ahearing aid; and (3) assist in theadjustment of hearing aids while in useby the patient. It is used by ENTprofessionals and in clinics for hearingaid fitting. This device can either be soldindividually or together with other Unity 2modules.		ACAM 5 is intended as an aid indiagnosing hearing loss and fitting ofhearing aids. The device consists of anaudiometer that can be used individuallyor with the other ACAM modules forperforming Real Ear Measurements(REM), Hearing Instrument Test (HIT)and loudness scaling. ACAM 5 shouldbe used by persons trained in audiologyon patients of any age who are able tounderstand the basic principles of thetest method when explained by theoperator.
Target population	Individuals of any age who havedemonstrated hearing loss, and who areable to understand and respond to thebasic principles of the test method whenexplained by the operator.		Individuals of any age who havedemonstrated hearing loss, and who areable to understand and respond to thebasic principles of the test method whenexplained by the operator
Anatomical sites	Ear		Ear
Where used	Clinics and on-site applications		Clinics and on-site applications
Energy usedand/or delivered	Hz	dB HL	Hz	dB HL
Air lineHeadphones	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 lineHeadphones	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
DeviceSpecifications	Siemens Unity 2 with HIA and Probe		ACAM 5
Energy usedand/or delivered	Hz	dB HL	Hz	dB HL
Air Line Speakers	1252505007501000150020003000400060008000	8090909090909090908065	1252505007501000150020003000400060008000	688595959595951001009575
Human factors	Subjective loudness response		Subjective loudness response
Design	Modular components consisting of:Audiometer and headphones, externalspeakers, hearing instrument test boxand microphone, software		Modular components consisting of:Audiometer and headphones, externalspeakers, hearing instrument test boxand microphone, software
Testing Features	• Real Ear measurement• Pure tone and speech audiometry• Loudness scaling and noise impulseaudiometry• ISTS. International Speech TestSignal• Pediatric audiometry, if requested• Automated fitting report• Percentile analysis		• Real Ear measurement• Pure tone and speech audiometry• Loudness scaling and noise impulseaudiometry• ISTS. International Speech TestSignal• Pediatric audiometry, if requested• Automated fitting report• Percentile Analysis
Available Tests	Audiometer:• Air conduction• Bone conduction• Free field (10 W integrated 2-channelamplifier)		Audiometer:• Air conduction• Bone conduction• Free field 4 Channel Standard(optional up to 12 Channel) with 20WPower
Tests conductedabove hearingthreshold	• SISI test• ABLB test (Fowler)• DLI test (Luescher)• Stenger test• Tone decay test (Carhart)		• ABLB test (Fowler)• Stenger test• Tone decay test (Carhart)• Speech Audiometry in quiet and inNoise• ANL(acceptable Noise Level)
Tests conductedabove hearingthreshold	• SISI test• ABLB test (Fowler)• DLI test (Luescher)• Stenger test• Tone decay test (Carhart)		• ABLB test (Fowler)• Stenger test• Tone decay test (Carhart)• Speech Audiometry in quiet and inNoise• ANL (acceptable Noise Level)

Table of Similarities and Differences

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Table of Similarities and Differences, continued

: .

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DeviceSpecifications	Siemens Unity 2 with HIA and Probe	ACAM 5
Additional TestsOffered	• REUR (Real Ear Unaided Response),• OEG (Open Ear Gain)• REOR (Real Ear Occluded Response)• REAR (Real Ear Aided Response,SPL level at the eardrum)	• REUR (Real Ear Unaided Response),• OEG (Open Ear Gain)• REAR (Real Ear Aided Response,SPL level at the eardrum)
	• REIG (Real Ear Insertion Gain)• RECD (Real Ear-to-CouplerDifference)• LI/LO (Input-/Output curve)• Sound Mapping• On top mode• Percentile analysis	• REIG (Real Ear Insertion Gain)• RECD (Real Ear-to-CouplerDifference)• LI/LO (Input-/Output curve)• Percentile analysis
Technicalspecifications	Common Data for all Applications:• Frequency Accuracy: ± 1 %• FFT: Resolution 1024 points,Averaging: 10-100• Intensity Accuracy: ± 1.5 dB• Sweep Speed: 1.5 - 12 sec./decade at25 Hz warble frequency (dependingon frequency resolution)• Frequency Resolution: 1/3, 1/6, 1/12and 1/24 octave• Stimulus Distortion: Less than 1 %THD	Common Data for all Applications:• Frequency Accuracy: < 1 %• FFT: Resolution 2048 points,Averaging: 10-100• Intensity Accuracy: ± 1.5 dB• Sweep Speed: 1.5 - 12 sec./decade at25 Hz warble frequency (dependingon frequency resolution)• Frequency Resolution: up to 2048points between 100Hz and 10kHz• Stimulus Distortion: Less than 1 %THD
Frequency Range	• 125 Hz - 8 kHz (AC & free field)• 125 Hz - 16 kHz (AC, HF mode)• 250 Hz - 6 kHz (BC)	• 125 Hz - 8 kHz (AC & free field)• No HF mode• 125 Hz - 8 kHz (BC)
Stimulus-Signal	• Pure tone, warble,• Noise signals: White, narrow band,speech• ILTASS	• Pure tone, warble,• Noise signals: White, narrow band,speech
MeasurementIntensity Range	• AC: -10 - 130 dB HL• BC: -10 - 80 dB HL	• AC: -10 - 120 dB HL• BC: -10 - 70 dB HL
Frequency Range	• 125 Hz - 8 kHz (AC & free field)• 125 Hz - 16 kHz (AC, HF mode)• 250 Hz - 6 kHz (BC)	Audiometry• 125 Hz - 8 kHz (AC, BC & free field)HIT & REM• 100 Hz - 10 kHz
Target gainformulas	NAL-NL1 and DSL i/o; NAL-RP, Berger,Pogo II, 1/3 Gain, 1/2 Gain, Fig6 (K-AMp)	NAL-NL1, DSL i/o, DSL mio; NAL-RP,Berger, Pogo II, 1/3 Gain, 1/2 Gain, Fig6(K-AMP), IDM, own Rules
Stimulus-Signal:	• Pure tone, warble,• Noise signals: Narrow band, White,Pink, Speech, ILTASS, ICRA, Chirp,patient voice	• Pure tone, warble, CHIRP, Burst• Noise signals: Narrow band, White,Pink, Speech, ICRA,• Real Signals: Speech, ISTS (about200 live Signals)
Test IntensityRange	Adjustable increments of 1 dB• Speaker: 40 - 100 dB SPL	Adjustable increments of 1.dB• Speaker: 0 - 100 dB SPL• Open headphones: 0 - 100 dB SPL• Insertion Earphones: 40 - 140 SPL
Device	Siemens Unity 2 with HIA and Probe	ACAM 5
SpecificationsMeasurement	• 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	• Attack/Release Time
	• Reference Test Gain	• Reference Test Gain
	• Frequency Response	• Frequency Response
	• Equivalent Input Noise	• Equivalent Input Noise
	• Harmonic Distortion	• Harmonic Distortion
	• Battery Current Drain	• Battery Current Drain
	• Automatic test sequence acc. to EN60118 or ANSI 3.22 (customizable)	• Automatic test sequence acc. to EN60118 or ANSI 3.22 (customizable)
	• Percentile analysis	• Delay Time (Group Delay)
		• Percentile analysis
		• Dynamic Compression Ratio
		• Long Term Test
		• Sonogram
		• Amplitude statistics
		• Loudness
		• Roughness
		• Spectrum of envelope
		• Intermodulation
		• Reverberation time
		• Induction
Loudspeaker:	integrated test box speaker	integrated test box speaker
Hearing Instrument test box
Technical specifications
Telecoil drivein test box	10 - 100 mA/Meter	0.01mA/meter - 1 A/meter
Total HarmonicDistortion	Ranges 0 - 55%, Resolution 0.1 %	Ranges 0 - 100 %, Resolution 0.1 %
Battery-Simulator:	Standard types are selectable, Customtypes within 1.1 - 1.6 V,0 - 25 Ohmrange	Voltage adjustable 0 to 3V (resolution0.01Volt)
Battery CurrentTest:	• Ranges: 0 - 50 mA• Resolution: 0.1 mA• Accuracy: ± 5 %	• Ranges: 0 - >20 mA• Resolution: 0.01 mA• Accuracy: ± 5 %
ComputerCommunication:	Built-in USB1.1 computer interface.Windows software available	Network Protocol TCP/IP over TwistedPair (Standard Network Interface)
SupportedOperating systems:	Windows 98 SE and higher (exceptWindows NT)	Windows XP SP3
DeviceSpecifications	Siemens Unity 2 with HIA and Probe	ACAM 5
Construction	Anodized all-aluminium case	Industry 19" Rack
Power	AC 50/60 Hz, 100 - 240V, 5 x 20 mm,	AC 50/60 Hz, 100 - 240V, 2 X 1 AT
Fuses	2.15 AT
Consumption	75 W	110W
Dimensions (cm)	• Control Unit: 31.9L x 31.7W x 7.5H• Docking Station: 42.8L x 23.0X x 22.2H	• Control Unit: 36L x 36.5W x 14H• Open Test Box, Small: 20L x 20X x 12H• Closed Test Box, Large: 40L x 33 x 30H
Standards Met	Audiometer	Audiometer
	EN 60645-1	EN 60645-1
	EN 60645-2	EN 60645-2
	EN 60645-4	ISO 8253 - 1,2,3
	ANSI S3.6	ISO 16832
	ANSI S3.22	ANSI S3.6
		ANSI S3.22
	Hearing Instrument Analyzer	Hearing Instrument Analyzer
	EN 60118-0	EN 60118-0
	EN 60118-7	EN 60118-7
	ANSI S3.43	ISO 12124
		ANSI S3.43
Materials	NA	NA
Biocompatibility	NA	NA
Compatibility with theenvironment andother devices	NA	NA
Sterility	NA	NA
Electrical safety	EN 60601-1, Class 1, Type BEN 60601-1-2	EN 60601-1, Class 1, Type BEN 60601-1-2
Mechanical safety	NA	NA
Chemical safety	NA	NA
Thermal safety	NA	NA
Radiation safety	NA	NA

Table of Similarities and Differences, continued

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Table of Similarities and Differences, continued

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Table of Similarities and Differences, continued

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510(k) Summary, Performance Test Data and Conclusions

Performance Test Data and Conclusions

As is the case with the predicate device, the ACAM system was subjected to electrical safety and electromagnetic compatibility testing and performance specifications and was found to be in compliance with the requirements of the international consensus standards shown below. Conformity with the requirements of these standards demonstrates that the ACAM System is safe and effective and is substantially equivalent to the predicate device.

Safetv:

The ACAM System has been designed, constructed and tested to meet the safety and performance requirements of various national safety codes and standards. The ACAM System complies with the following international safety standards:

. EN 60601-1 1996-03 Medical electrical equipment: Part 1: General requirements for safety: (FDA Recognition # 5-4)
EN 60601-1-1:2001 Medical electrical equipment; Part 1-1: General requirements for safety; . 1. Collateral standard: Safety requirements for medical electrical systems (FDA Recognition # 5-27)
EN 60601-1-2:2001 Medical electrical equipment; Part 1: General requirements for safety; . 2. Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA Recognition # 5-30)

Effectiveness:

The effectiveness of the ACAM System has been shown through testing in accordance with the following international standards:

ANSI S3.6-2004. Specification for Audiometers. (FDA Recognition # 4-123) .
ANSI S3.46-1997(R2007). Methods of Measurement of Real-Ear Performance . Characteristics of Hearing Aids (FDA Recognition # 4-175)
ANSI S3.22-2003. Specification of Hearing Aid Characteristics (FDA Recognition # 4-124) .

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Acousticon GmbH c/o Ms. Maureen N. Garner President New World Regulatory Solutions, Inc. P.O. Box 5374 Toms River, NJ 08754

APR = 8 2011

Re: K103298

Trade/Device Name: ACAM® 5 Audiometer System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: March 25, 2011 Received: March 29, 2011

Dear Ms. Garner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{10}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melvin R. Felder, M.D.

Malvina B. Evdelman. M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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103298

INDICATIONS FOR USE

510(k) Number K103298

Device Name: ACAM® 5

Prescription

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.

AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Over-The-Counter

Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Use

Signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103298

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.