(104 days)
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No
The summary describes a device that uses ultrasonic technology to create a directional sound beam for improved clarity. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned likely controls the ultrasonic beam and audio processing, not AI/ML algorithms.
Yes
The device is indicated to "improve clarity and comprehension of sounds" and clinical studies show it leads to "significant gains in speech understanding" in individuals with hearing loss, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an auditory trainer/group hearing aid designed to improve clarity and comprehension of sounds, not to diagnose a condition. Its purpose is to transmit sound effectively to listeners, including those with hearing loss, and its performance studies relate to sound intelligibility and speech understanding, not diagnosis.
No
The device description explicitly states that the device consists of an amplifier, software, and an emitter (speaker), indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The HyperSound Group Auditory Trainer is a system that transmits sound to improve clarity and comprehension for listeners. It does not interact with or analyze any biological specimens.
- Intended Use: The intended use is to function as a group auditory trainer or group hearing aid, which is a device that assists with hearing, not a diagnostic tool that analyzes biological samples.
- Device Description: The description details a sound system with an amplifier, software, and emitter. There is no mention of components or processes related to handling or analyzing biological specimens.
Therefore, the HyperSound Group Auditory Trainer falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EPF
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.
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
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Indicated Patient Age Range
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Intended User / Care Setting
The HyperSound Audio System is intended to be used to improve the clarity of sound in the home, business, school or other institutional environment.
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)
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.
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
§ 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.
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 -
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.
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 -
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.
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.
| Device
Proprietary Name | Submitted Device
HyperSound Audio System | Easy Listener 2 FM |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Being submitted | K043090 |
| Device Classification
Type and
Classification Name | Class II
Group hearing aid or auditory trainer | Class II
Group 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 be
used to improve the clarity of sound in the
home, business, school or other institutional
environment by individuals or groups with or
without hearing loss and with or without hearing
aids. The device is intended to overcome any
negative effects of distance, poor room
acoustics and background noise to improve
clarity (speech understanding and speech
discrimination) for those with normal hearing or
the hearing impaired with mild to severe hearing
loss without earphones or ear- molds. | Sound Field wireless amplification systems are
intended for use as group auditory trainers used to
communicate simultaneously with one or more
listeners with normal hearing or hearing impairments.
The device is used with an associated transmitter
microphone and speakers systems and does not
provide coupling to the ear through either earphones
or ear molds. The use of FM systems also reduces the
detrimental effects caused by the distance between
the speaker or sound source and the hearing impaired
listener. |
| Indications for Use | 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
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. | Sound Field wireless amplification systems are
intended for use as group auditory trainers used to
communicate simultaneously with one or more
listeners with normal hearing or hearing impairments.
The device is used with an associated transmitter
microphone and speakers systems and does not
provide coupling to the ear through either earphones
or ear molds.
These systems use FE and/or wireless technology
which include receivers, transmitters, and strategic
placement of high quality speaker systems and can be
used with or without BTE hearing aids nad/or personal
FM devices. The talker's voice is mildly amplified and
dispersed throughout the room to assist listeners,
regardless of seating location, to consistently hear
whatever the talker is saying. |
| Overall Design | A microphone, CD/DVD or other sound source is
routed to an amplifier, which mixes audible
sound with an ultrasonic carrier. The output is
sent to specially designed emitters (speakers),
which deliver the waves to produce sound into
the air through a conical beam. The waves begin
to demodulate into high quality sound waves
within six inches of the emitter and continue to
travel within a conical beam to the desired area.
The sound is clearly delivered to the listener at
normal volume levels free with reduced external
noise. The HSS System may be portable or
installed permanently by a sound contractor. | The device consists of FM or IR transmitters and
microphone used by a speaker to send auditory signals
to FM or IR receiver/amplifier which processes the
voice signals and broadcasts the signals through one or
more loudspeakers. These systems may be installed by
a sound contractor. Sound is reproduced by the
speaker or speaker systems to recreate the sound at a
slightly increased volume level. |
| Device
Proprietary Name | Submitted Device
HyperSound Audio System | Easy Listener 2 FM |
| How it Works | HSS electronically mixes audible sound with an
ultrasonic carrier. These audible tones are
projected within a beam of silent energy heard
by those in the targeted area. Unlike a
conventional speaker, sound is not created
omni-directionally at the emitter (speaker)
surface but is created along and within a highly
directional air column. Sound is only heard if a
listener's head is within the beam or the beam
hits a reflective surface whereupon sound is
created at the point of reflection. This sound,
which is created in the air, can be directed to
nearly any desired point in the listening
environment, controlling the direction of sound. | The system works essentially as a monaural or stereo
system for the processing of sound input through the
amplifier for delivery to the speakers placed throughout
the audience. Sound is not directional and outside noise
may comingle with.the sound delivered. FM or IR are
used in lieu of cables, but serve the same purpose. |
| Physical dimensions | Amplifier 6x6x1.5 inches, individual or
multiple emitters: 12.5x6.5x1 inches | Varies based on type of FM transmitter, receiver
and speaker(s) employed |
| Maximum audio
output
characteristics | 89dB SPL @ 1m | 90dB SPL @ 1m |
| Frequency range | Generally 300Hz to 18kHz (may be used with off-
shelf consumer powered woofer where
improved bass (lower frequencies) is desired) | Generally 50Hz to 20kHz depending on speaker size
type |
| Energy used | 30 dB and word discrimination scores of