The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

Device Description

The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that delivers beamlike sound that is clear to the listener. The beamed audio content begins to demodulate in the air within six inches of the emitter and results in a cone-like transmission of sound waves that can be directed towards the listener. This device is intended for sale as an over-the-counter product and can be used with any sound source and at any distance from 3 feet to 50 feet or more from the emitters (speakers). Ultrasonic technology has been used for many years in industry and is also utilized in medical devices, such as ultrasonic nebulizers. The ultrasonic sound waves this product is based upon have also used in commercial and localized communications, and they are below the ultrasonic sound safety limits established by OSHA as required by OSHA Noise Standard, 29 CFR 1910.95. The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Benchmarking / Equivalence Standard)	Reported Device Performance (HyperSound Audio System)
ANSI S3.2-2009 Modified Rhyme Test (MRT) score	Mean score of 91%
Speech understanding improvement for hearing-impaired subjects (compared to conventional speakers at 70 dB)	Median AZBio scores increased from 0.0% to 34.9% (quiet), and from 1.8% to 51.6% (noise). Median CNC whole word test scores increased from 0.0% to 54.0%. Median phoneme test scores from 4.0% to 63.4%. (All with p=0.008 or p=0.004)

Note: The document focuses on demonstrating substantial equivalence rather than defining explicit acceptance criteria in a quantitative pass/fail manner. The reported performance metrics are used to support this claim of equivalence and clinical effectiveness.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 10 adult patients with mild to severe hearing loss.
- Data Provenance: Clinical study conducted at the California Hearing and Balance Center in La Jolla, CA (USA). Prospective data from a controlled audiology laboratory.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts establishing ground truth for the test set. However, a "controlled audiology laboratory" suggests that audiologists or similarly qualified professionals would have conducted and interpreted the speech tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The study was a "single-blinded, randomized cross over clinical study," but no details on expert adjudication of results are provided beyond standard audiology testing procedures.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is not an AI-assisted diagnostic tool, but rather an auditory trainer. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable. The clinical study does compare the HSS system to conventional speakers, showing a significant improvement in speech understanding with the HSS.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for the non-clinical testing, "Equivalency testing to a predicate device was performed by an independent laboratory pursuant to ANSI S3.2-2009," which would be a standalone assessment of the device's audio output characteristics.
- The clinical study assessed the device's performance directly with human users, but it's not an "algorithm only" test as the device itself is a physical auditory system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical study was established by standardized audiological speech tests: Modified Rhyme Test (MRT), Consonant-Nucleus-Consonant (CNC) in quiet, and AzBio in noise. These are objective measures of speech understanding, which serve as the "ground truth" for evaluating the hearing device's effectiveness.
The sample size for the training set:
- This device is not an AI/ML model that requires a "training set." It is an auditory trainer employing ultrasonic technology. The design and performance are based on engineering principles and verified through bench testing and clinical studies, not machine learning training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

510(k) Summary HyperSound Health Audio System Model HSS-3000 (HSS) – Group Auditory Trainer 510(k) Number: K133352

1. Submission Sponsor -

HyperSound Health, Inc. 13771 Danielson Street, Ste. L Poway, California 92064 USA Phone: 888-496-8001 Fax: 888-639-2150 Contact: Gus Bock, Management Representative

2. Date Prepared -

October 23, 2013

3. Device Name -

Trade/Proprietary Name:	HyperSound Audio System (HSS)
Common/Usual Name:	Group Auditory Trainer
Classification Name:	Group Auditory Trainer or Group Hearing Aid
Classification Regulation:	874.3320
Classification Panel:	Ear Nose and Throat
Product Code :	EPF
Device Class:	Class II
K Number:	K133352
FDA Establishment Registration #:	348096

4. Predicate Device -

(1) Phonic Ear, Inc. K043090, SE: 12/23/2004

5. Device Description -

{1}------------------------------------------------

The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.,

6. Indications for Use -

7. Technological Characteristics and Substantial Equivalence -

The following table compares the HyperSound Audio System to the Predicate Devices with respect to intended use, technological characteristics and principles of operation. These comparisons provide more detailed information regarding the basis for the determination of substantial equivalence.

The HyperSound Audio System (HSS) shares the same basic technology as standard consumer amplifiers and speakers as well as those speakers used in certain group auditory trainers, group hearing aids and assistive listening devices. Similar and substantially equivalent to K043090 (Easy Listener 2 FM) and other sound field amplification systems, HSS employs reproducing audio in the air and not through any coupling to the ear through either earphones or ear molds. There is no contact with the body. HSS is also substantially equivalent to various types of approved Group Hearing Aids or Group Auditory Trainers that are directly connected or coupled to the listener with similar results.

DeviceProprietary Name	Submitted DeviceHyperSound Audio System	Easy Listener 2 FM
510(k) Number	Being submitted	K043090
Device ClassificationType andClassification Name	Class IIGroup hearing aid or auditory trainer	Class IIGroup hearing aid or auditory trainer
Manufacturer	HyperSound Health, Inc.	Phonic Ear, Inc.
Product Code	EPF	EPF
Regulation Number	874.3320	874.3320
Device	Submitted Device
Proprietary Name	HyperSound Audio System	Easy Listener 2 FM
Intended Use	The HyperSound Audio System is intended to beused to improve the clarity of sound in thehome, business, school or other institutionalenvironment by individuals or groups with orwithout hearing loss and with or without hearingaids. The device is intended to overcome anynegative effects of distance, poor roomacoustics and background noise to improveclarity (speech understanding and speechdiscrimination) for those with normal hearing orthe hearing impaired with mild to severe hearingloss without earphones or ear- molds.	Sound Field wireless amplification systems areintended for use as group auditory trainers used tocommunicate simultaneously with one or morelisteners with normal hearing or hearing impairments.The device is used with an associated transmittermicrophone and speakers systems and does notprovide coupling to the ear through either earphonesor ear molds. The use of FM systems also reduces thedetrimental effects caused by the distance betweenthe speaker or sound source and the hearing impairedlistener.
Indications for Use	The HyperSound Group Auditory Trainer isindicated for use as a group auditory trainer orgroup hearing aid used to communicatesimultaneously with one or more listeners withor without hearing loss and with or withouthearing aids in order to improve clarity andcomprehension of sounds generated fromsources such as a microphone, CD/DVD player,TV, Stereo System or other sound generationsystems.	Sound Field wireless amplification systems areintended for use as group auditory trainers used tocommunicate simultaneously with one or morelisteners with normal hearing or hearing impairments.The device is used with an associated transmittermicrophone and speakers systems and does notprovide coupling to the ear through either earphonesor ear molds.These systems use FE and/or wireless technologywhich include receivers, transmitters, and strategicplacement of high quality speaker systems and can beused with or without BTE hearing aids nad/or personalFM devices. The talker's voice is mildly amplified anddispersed throughout the room to assist listeners,regardless of seating location, to consistently hearwhatever the talker is saying.
Overall Design	A microphone, CD/DVD or other sound source isrouted to an amplifier, which mixes audiblesound with an ultrasonic carrier. The output issent to specially designed emitters (speakers),which deliver the waves to produce sound intothe air through a conical beam. The waves beginto demodulate into high quality sound waveswithin six inches of the emitter and continue totravel within a conical beam to the desired area.The sound is clearly delivered to the listener atnormal volume levels free with reduced externalnoise. The HSS System may be portable orinstalled permanently by a sound contractor.	The device consists of FM or IR transmitters andmicrophone used by a speaker to send auditory signalsto FM or IR receiver/amplifier which processes thevoice signals and broadcasts the signals through one ormore loudspeakers. These systems may be installed bya sound contractor. Sound is reproduced by thespeaker or speaker systems to recreate the sound at aslightly increased volume level.
DeviceProprietary Name	Submitted DeviceHyperSound Audio System	Easy Listener 2 FM
How it Works	HSS electronically mixes audible sound with anultrasonic carrier. These audible tones areprojected within a beam of silent energy heardby those in the targeted area. Unlike aconventional speaker, sound is not createdomni-directionally at the emitter (speaker)surface but is created along and within a highlydirectional air column. Sound is only heard if alistener's head is within the beam or the beamhits a reflective surface whereupon sound iscreated at the point of reflection. This sound,which is created in the air, can be directed tonearly any desired point in the listeningenvironment, controlling the direction of sound.	The system works essentially as a monaural or stereosystem for the processing of sound input through theamplifier for delivery to the speakers placed throughoutthe audience. Sound is not directional and outside noisemay comingle with.the sound delivered. FM or IR areused in lieu of cables, but serve the same purpose.
Physical dimensions	Amplifier 6x6x1.5 inches, individual ormultiple emitters: 12.5x6.5x1 inches	Varies based on type of FM transmitter, receiverand speaker(s) employed
Maximum audiooutputcharacteristics	89dB SPL @ 1m	90dB SPL @ 1m
Frequency range	Generally 300Hz to 18kHz (may be used with off-shelf consumer powered woofer whereimproved bass (lower frequencies) is desired)	Generally 50Hz to 20kHz depending on speaker sizetype
Energy used	< 15 watts per channel	Generally 30W per speaker
Transducer type	Custom emitter (speaker)	Conventional speaker
Safety	HyperSound delivers audio through the airwithin a conical beam and without any earphoneor ear mold to deliver sound free of externalsounds or sources of distortion.Users are instructed to not aim an emitter(speaker) directly in to the ear canal of anindividual at less than 3 feet distance.The amplifier is CE compliant, FCC compliant(Part 15, Subpart B) and approved for ElectricalSafety by Nemko CCL (Nationally Recognized)	There are no known contraindications associatedwith the use of sound field group amplificationsystems.Many case studies, experiments, and trials exist thatdocument the benefits and effectiveness of speechperception from sound field amplification.Amplifier and speakers meet FCC and ConsumerElectrical Safety requirements.

...

{2}------------------------------------------------

ﺑ

{3}------------------------------------------------

{4}------------------------------------------------

8. Non-Clinical Testing

Comparable systems using the same technology as the HyperSound Audio System have been in commercial use since 2001 for general audio use primarily commercial advertising systems. The manufacturer has submitted the applicable report to the FDA pursuant to the Radiation Control for Health and Safety Act of 1968 (Title 21, CFR, sub-chapter J) as it pertains to ultrasonic devices. Laboratory bench testing, comparative testing and verifications related to device performance, production of sound volume over distance, has demonstrated the HyperSound Audio System consistently and safely delivers clear and understandable sounds, letters and words to the patient or to the listener at distances from 3 feet to 50 feet or more with sound levels of up to 76.5 dB in normal listening and sound reproduction environments.

Both sound pressure level measurement and sound beam plotting measurements were performed to demonstrate equivalent output at various distances. Beam plotting demonstrated focused delivery of frequencies important to speech discrimination in a targeted beam important to augment hearing for selected users in home, classroom or other group settings without the need for headphones or segregation.

Equivalency testing to a predicate device was performed by an independent laboratory pursuant to ANSI S3.2-2009-American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems. Testing of the HSS system demonstrated a mean ANSI S3.2-2099 MRT (Modified Rhyme Test) score of 91% and the predicate device had a mean score of 79.2% demonstrating more than equivalency in word list discrimination amongst normal subjects.

9. Clinical Testing -

A clinical study was conducted by the California Hearing and Balance Center in La Jolla, CA under a formal, written, Institutional Review Board (IRB) approved protocol. The clinical study was performed in a controlled audiology laboratory as a single-blinded, randomized cross over clinical study using adult subjects with hearing loss ranging from mild to severe degree. Testing was based upon speech tests (such as Modified Rhyme Test (MRT) and Consonant-Nucleus-Consonant or CNC in quiet and AzBio in noise) to assess the effectiveness of the HSS System compared to conventional speakers at comparable volume levels.

Ten adult patients with mild to severe hearing loss with pure-tone average (PTA) of > 30 dB and word discrimination scores of < 80% in both ears were tested at one meter distance from the audio source. Significant gains in speech understanding were associated with the HSS versus conventional speaker for all test conditions at 70 dB. Median AZBio scores increased from 0.0% to 34.9% (p=0.008) in quiet, and from 1.8% to 51.6% in noise (p=0.008). Median CNC whole word test scores increased from 0.0% to 54.0% (p=0.004) and median phoneme test scores from 4.0% to 63.4% (p=0.004).

Data and results demonstrated improvement in sound clarity over conventional speakers at 70 dB, including in background noise, in those with mild to severe hearing loss.

{5}------------------------------------------------

10. Conclusion -

By definition, a subject device (new device) is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device or the subject device has the same intended use and different technological characteristics that subject device can be demonstrated to be substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The HyperSound Audio System meets these criteria, and as designed and manufactured, is considered to be substantially equivalent to the referenced predicate devices based on testing and clinical evaluation.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

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

February 12, 2014

HyperSound Health, Inc. c/o Mr. James Barnes 13771 Danielson Street, Ste. L Poway, CA 92064

Re: K133352

Trade/Device Name: HyperSound Audio System (HSS) Regulation Number: 21 CFR 874.3320 Regulation Name: Group Auditory Trainer or Group Hearing Aid Regulatory Class: Class II Product Code: EPF Dated: January 15, 2014 Received: January 16, 2014

Dear Mr. Barnes:

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, listing 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.

{7}------------------------------------------------

Page 2 - Mr. James Barnes ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.

Eric A. Mann -S

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

Enclosure

{8}------------------------------------------------

Indications for Use Statement

HyperSound Health Audio System Model HSS-3000 (HSS) - Group Auditory Trainer 510(k) Number: K133352

Device Name: HyperSound Health Audio System Model HSS-3000 (HSS) - Group Auditory Trainer

Indications for Use:

The HyperSound Group Auditory Trainer is indicated for use as a group avditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

_ {Part 21 CFR 801 Subpart D} Prescription Use _ AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cherish R. Giusto -A

Regulation Number and Section

§ 874.3320 Group hearing aid or group auditory trainer.

(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(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.