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Communication Systems & Equipment

Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Page 1: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

CommunicationSystems & Equipment

Page 2: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,
Page 3: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

3

Welcome to our new-look Communications Catalogue

Intr

oduc

tion

+44 (0)1634 733883 [email protected] www.puretone.net +44 (0)1634 733883 [email protected] www.puretone.net

We thank you for your continued support and would like to remind you that if there is any specific communication product that is not in our catalogue, please contact

us and we will endeavour to source the item for you at a competitive price.

We also offer quantity discounts on bulk orders. Please contact our sales team to discuss your exact needs.

Established in 1976, Puretone remains a friendly, family-run company and is the only independent designer and manufacturer of hearing & tinnitus systems in the UK.

We are proud to offer products that satisfy your mainstream and specialist needs at competitive prices.

Kind regards

Baz ChoudhryManaging Director

Puretone Ltd

Page 4: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Cont

ents

By emailEmail your order to us at [email protected]

By PostSend your order to Puretone Ltd, 9-10 Henley Business Park Trident Close, Medway City Estate, Rochester, Kent, ME2 4FR. UK

By FaxFax your order direct to us on +44 (0)1634 719 450

By PhoneCall our sales team on +44 (0)1634 733 883

OnlineBrowse our range at www.puretone.net

How to order

15-18Custom Headsets

19-22Custom 2 Way Comms

9-14Wireless & Covert Earpieces

5-8Tubed Earpieces

23-25Headset Earpieces

Page 5: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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+44 (0)1634 733883 [email protected] www.puretone.net

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By FaxFax your order direct to us on +44 (0)1634 719 450

Page 6: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Custom Presenters’ Earmould

Custom-Made From An Ear Impression

Ensures maximum comfort and a secure fit.

Manufactured in either hard acrylic, soft acrylic or

silicone. Supplied with coiled tubing, shirt collar clip and

adaptor. Transparent colour (other colours

available on request).

Custom Presenters Mould Hard Acrylic:Soft Acrylic:Silicone:

ACC148SET-HARDACC148SET-SOFTACC148SET-SIL

Invisi Loop

Universal Fit Eartip With Tubing

Generic fitting clear eartip connected to straight or coiled tubing

and receiver adaptor.

Invisi Loop StraightSize 1:Size 2:Size 3:Size 4:Size 5:

Invisi Loop CoiledSize 1:Size 2:Size 3:Size 4:Size 5:

ACC396AACC396BACC396CACC396DACC396E

ACC397AACC397BACC397CACC397DACC397E

Invisi Loop Straight

Invisi Loop Coiled

Page 7: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Standard Presenters Mould With AttenuatorSmall Left:Small Right:Medium Left:Medium Right:Large Left:Large Right:

Standard Presenters Mould With 90 degree bendSmall Left:Small Right:Medium Left:Medium Right:Large Left:Large Right:

Standard Presenters Mould With TubingSmall Left:Small Right:Medium Left:Medium Right:Large Left:Large Right:

Standard Presenters Mould No TubingSmall Left:Small Right:Medium Left: Medium Right:Large Left:Large Right:

Standard Presenters’ Earmould

Universal Fit Earmould

Available in 3 sizes, for left and right ears, with the option of an attenuator for volume control.

Manufactured in silicone. Supplied with coiled tubing, shirt collar clip and adaptor. Beige colour.

ACC342AACC342DACC342BACC342EACC342CACC342F

ACC342HACC342JACC342KACC342LACC342MACC342N

ACC149LACC149PACC149MACC149QACC149PACC149R

ACC149SACC149VACC149TACC149WACC149UACC149X

Tubed Earmould Accessories

We offer a wide range of high quality tubed earmould accessories to suit every need.

Broadcast QualityShirt Clip For

Presenters MouldsACC148LNC

Coiled Tubing Clear

ACC148QReceiver AdaptorWith Metal ClipACC145A

2-Pin Receiver

ACC120J

2-Pin Receiver cord (3.5mm Jack)ACC122D

Straight Tubing

ACC163

Shirt Clip For Presenters Moulds

ACC148L

Coiled Tubing Black

ACC148Q-BLK

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Soft Shaped Ear Tips

Soft shaped clear ear tips. Available in 3 sizes, with or without tubes. Supplied individually.

Anti-Feedback Soft Ear Tips

Available in multiple sizes in clear or pink, with or without tubes. Supplied individually.

Pink Without TubesVery Small:Small:Large:Very Large:

Clear Without TubesVery Small:Small:Medium:Large:Very Large:

Pink With TubesVery Small:Small:Medium:Large:Very Large:Extra Large:

Clear With TubesVery Small:Small:Medium:Large:Very Large:Extra Large:

ACC101QACC101NACC101PACC101R

ACC101SACC101TACC101UACC101VACC101W

ACC101AACC101BACC101CACC101DACC101EACC101F

ACC101GACC101HACC101JACC101KACC101LACC101M

Small With TubeLeft:Right:

Medium With TubeLeft:Right:

Large With TubeLeft:Right:

Without TubeSmall:Medium:Large:

ACC102AACC102D

ACC102BACC102E

ACC102CACC102F

ACC102GACC102HACC102J

Page 9: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Covert Communication

The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal, so the

sound received from an inductive loop can be fed directly to the ear drum preventing those standing in close

proximity from over hearing the communication.

Their size mean that they seat deep into the ear so as not to be visible from the outside. Each device is powered

from a small Zinc Air battery which is readily available and easily replaced by the user. The user will need to

wear either a neck loop or a SRC harness under their outer clothing. This will transmit the sound locally to the

earpiece. The localisation will also prevent cross talk between two users standing next to each other so secure

communications is retained.

The latest sub miniature Digital DSP amplifiers are used to amplify the

sound received from the loop providing a clear crisp sound. Soft squelch

is a feature of all these earpieces. This reduces the noise induced into

the earpieces by spurious radio signals given off by many of today`s

electronic equipment. Depending on the model selected, this soft

squelch may be continuously on or have a switch to override it.

The generic devices will fit the majority of people, but custom-made

versions are available with the same functionality for those wishing

additional comfort, secure fitting and less visibility. For more information

on custom-made earpieces, including ear impression taking services

in your area please visit our website www.puretone.net or contact us

directly.

Digital Inductive Earpieces

Digital Inductive Earpieces & Accessories

IR1-D

Page 11: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Actual Size

See page 14 for consumable parts.

Anti-Feedback Sleeve

Ideal for eliminating

feedback in the ear.

Made of thin, soft silicone

which can be cut down to

size as needed.

Supplied individually.

Product Code: ACC168

IR1-D

IR2-D

IR3-D

IR4-D

IR55-D

If you require a custom made version please contact us for more information.

Page 12: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Stereo Neck Loop

Induction neck loop for

covert communication

with an earpiece.

Available in stereo.

Connection: 3.5mm Jack

Colour: Black

Length: 820mm

Product Code: NL-STEREO-SET

SRC Style C

• Neck loop with anti-choke

quick release

• Lapel microphone

• Torpedo palm PTT switch

Product Code: SRC-STYLE-C

SRC Style B

• Neck loop with anti-choke

quick release

• Lapel microphone

• Separate small PTT switch

and clip

Product Code: SRC-STYLE-B

• Neck loop with anti-choke

quick release

• Small PTT switch with integral

microphone

• Can be clipped to lapel

Product Code: SRC-STYLE-A

SRC Harness

The SRC harness provides a two way communications interface between a user’s propriority radio, to their

earpieces. The neck loop transmits to the device in the earpiece while the remote PTT and microphone provide

convenient transmit function. Includes Neck Loop with anti-choke quick release.

SRC Style A

Page 13: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Portable Loop System

The Portable Loop is a versatile solution, providing

mobile desktop assistance for your customers. It can

be moved between rooms as required and is used for

conversations between two people.

The single control unit is housed in robust ABS plastic

and incorporates the microphone, amplifier, hearing

loop aerial and rechargeable battery system.

Applications• Reception areas

• Shops

• Banks

• Information centres

Product Code: ACC338A

What’s Included• The Portable Loop

• Power supply

• Hearing loop signs

• Portable loop shelf

Home Loop Kit

The “Home Loop” is a sleek and powerful hearing loop

driver that connects to televisions and other audio

devices. It enables hearing aid wearers to listen

wirelessly directly from the source, providing the best

possible sound quality. Integrated clear audio

processing gives the user outstanding sound quality,

enhancing speech and music clarity.

Applications• Homes

• Small businesses

• Watching TV

• Listening to music

Product Code: ACC338M

Features• Quick setup

• Optical in

• Connect multiple devices

• Separate volume control

Under The Counter Loop Kit

The “Under the Counter” loop kit provides clear communication with hearing aid wearers, especially where high

background noise is a problem or clear speech is restricted. It has a flexible aerial that can be bent to shape,

allowing it to be installed into many different positions. The kit includes our halo indicator noise cancelling

microphone as standard for high performance and self-testing. A kit containing a small omni-directional

“mouse” microphone is also available.

Product Code: ACC338N (Halo mic)

Product Code: ACC338P (Mouse mic)

ApplicationsFor use in any situation where one to one

communication takes place at a counter, booth or

desk, such as in banks, post offices, supermarkets,

theatres, airports and information centres.

Features• Energy-saving “green” standby mode is achieving

a power saving of up to 80% during quiet periods

• Isolated audio line input allows the driver to take

alternative audio sources (optional)

• Advanced audio processing features AGC,

compression, and noise gate

• Microprocessor control

• Constant-current loop drive

• Continuous self-testing

• Power and LED status indication

Page 14: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Audimed Waxguard

Product Code: MM-FILTER-GREEN

NoWax

Product Code: ACC410A

Red (Right) Set: ACC315D-HF4Blue (Left) Set: ACC315C-HF4

Wax Guards

Wax guards are designed to protect the receiver of your earpiece from wax and moisture.

The prevention of wax and moisture build up is an integral part of ensuring the longevity of your in ear device.

Micro PureGuard

PureCell Plus Batteries

Replacement batteries for digital IR earpieces.

Supplied in a box of 60 cells.

Manufactured by Rayovac, these high quality

batteries give you great performance for great value,

helping you power your in ear devices for longer.

Up to 17% more power and up to 10% more mAh.

PureCell Plus 312: BAT312-PLUS-MFPureCell Plus 10: BAT10-PLUS-MF

Anti-Feedback Sleeve

Ideal for eliminating

feedback in the ear.

Made of thin, soft silicone which can be cut down to

size as needed. Supplied individually.

Product Code: ACC168

Page 15: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Page 16: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

WhiteNeonPink

BlackMagenta ClearBeige

Red YellowNeon Orange

Neon Green

Orange Neon Yellow

LilacAzure Blue

BlueGreen Cammo Green

Lime Green

Cust

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ets

Our range of custom-made headsets are available

with a huge variety of earpiece colours.

i-Monitor Pro

Product Code: i-MONITOR

Featuring twin steel armature drivers for excellent

sound quality, clear voice calls and enhanced

bass response, i-Monitors Pro allows you to

receive/end calls completely hands-free,

thanks to the in-line push button located

on the cable.

The control unit also features a built-in

microphone and volume control slider.

i-Monitor Pro are manufactured from soft, flexible

silicone, giving an ambient noise reduction of

approximately 25dB.

Control functions:

16

Silicone Earpiece Colour Options:

Earpiece Colour Options

Page 17: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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Product Code: I-MONITOR-BT

Control functions:

MotoSound

Product Code: MSOUND

Custom-made from soft flexible silicone to give

excellent comfort over long durations, fitting

deep in the ear canal, they create an acoustic

seal which lowers outside noise considerably,

allowing audio to be heard clearly.

Small & discreet, they fit in crash helmets, and are

ideal for motorcyclists or racing drivers who need

to have clear incoming communication & noise

protection while driving.

Features a fixed cable with

moulded 3.5mm jack plug.

i-Monitor Bluetooth™

Custom-Made Bluetooth™ Earpieces For Smart Phones

Featuring twin steel armature drivers for excellent sound quality, clear voice calls and enhanced bass response,

i-Monitor Bluetooth™ allows you to receive/end calls completely hands-free, thanks to the in-line push button

located on the cable. The control unit also features a built-in microphone and volume control buttons. i-Monitor

Bluetooth™ has been manufactured from soft, flexible silicone, giving an ambient noise reduction of approx. 25dB.

Page 18: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

CUST

OM

HEA

DSE

TSH

EAD

SET

EARP

IECE

S

Earmould sealant comfort gel for easier insertion and removal of in-ear devices, earpieces and earmoulds.

Order Code: ACC448B

PureClean Comfort Gel

Page 19: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

Cust

om 2

Way

Com

ms

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NanoComm XPM Headset

The NanoComm XPM is a versatile custom-made mono headset. NanoComm XPM can be tailored to suit any need

with 2 driver options, 3 earpiece options, 2 mic boom lengths, 5 mic options, 2 cable types, and the ability to add a

push to talk button, these options give the XPM over 1,000 unique configurations.

The headset simply clips onto custom made earmoulds (available separately).

Contact us to discuss your needs, or visit nanocomm.com/config to configure a headset.

Custom-Made Silicone Earpiece OptionThe NanoComm features a communications clip

system, which allows different earmoulds to be

attached to the boom microphone. Custom-made

NanoComm earmoulds are available with or

without filters, reducing external noise while still

allowing speech to be heard.

NanoComm XPS Headset

Contact us to discuss your needs, or visit nanocomm.com/config to configure a headset.

Custom-Made Silicone Earpiece OptionThe NanoComm features a communications clip

system, which allows different earmoulds to be

attached to the boom microphone. Custom-made

NanoComm earmoulds are available with or

without filters, reducing external noise while still

allowing speech to be heard.

The NanoComm XPS is a versatile custom-made stereo headset. NanoComm XPS can be tailored to suit any need

with 2 driver options, 3 earpiece options, 2 mic boom lengths, 5 mic options, 4 cable options, 3 junction box options,

and the ability to add a push to talk button, these options give the XPM over 10,000 unique configurations.

The headset simply clips onto custom made earmoulds (available separately).

Page 21: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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NanoComm Bluetooth™ Headset

A self contained Bluetooth™ headset with a noise reduction boom microphone and stereo output. Whether listening

to music or making a call the headset will keep your hands free. Ideal for sports and work environments.

The headset simply clips onto custom made earmoulds (available separately).

Product Code: NC2-BTV4.1

Technical specifications• Bluetooth version: 4.1

• Talk time: Up to 4.5 hours

• Music playback: Up to 6 hours

• Standby: Up to 7 days (175 Hours)

• Charge time: Less than 2 hours

• Charging port: Micro USB (with cover)

• Microphone: Electret noise reduction mic

• Mic boom: 128mm goose neck boom

• Cable length: 235mm (remote to earpiece)

• Weight: 12g (less ear moulds)

• Colour: Black

Electret noise reduction microphoneThe NanoComm Bluetooth™ is supplied with Electret

noise reduction mic with a 128mm goose neck boom

as standard. A windshield is also supplied and can

be upgraded to a waterproof windshield available

separately.

Close up of control unit

USB power cable

(included)

NanoComm Bluetooth™ Monitor

A self contained Bluetooth™ headset with a built in microphone and stereo output. Whether listening to music or

making a call the headset will keep your hands free. Ideal for sports and work environments.

The headset simply clips onto custom made earmoulds (available separately).

Product Code: NC2-BT-NB

Technical specifications• Bluetooth version: 4.1

• Talk time: Up to 4.5 hours

• Music playback: Up to 6 hours

• Standby: Up to 7 days (175 Hours)

• Charge time: Less than 2 hours

• Charging port: Micro USB (with cover)

• Microphone: Built in mic

• Cable length: 235mm (remote to earpiece)

• Weight: 12g (less ear moulds)

• Colour: Black

Close up of control unit

USB power cable

(included)

Page 22: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

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NanoComm GAV2 Aviation Headset

NanoComm GA from Puretone is an ultra-lightweight, custom-made aviation headset. The NanoComm GA weighs

only 4g, which is less than 3% of the weight of a standard traditional general aviation headset.

The headset features a 2.8mm diameter boom

microphone, coupled with a custom-moulded

ProtectHear comms earpiece in each ear, which

ensures an extremely comfortable fit when used for

extended periods. These soft silicone earpieces give

an SNR of 29dB (see table), while still allowing the

audio to be heard.

The NanoComm GA features a ‘Shape & Stay’ flexible boom microphone for clear, noise free communications, as

well as a quick-release lanyard, with cables running inside to each ear, thus keeping cables tidy.

NanoComm GA can be fitted with PJ055 & PJ068

jack plugs, Redel (Bose) Plug, Nato Plug, 5 - Din Plug

and Nexus Plug (Other connections may also be

made to order.)

Contact us to discuss your needs

General aviation

plug shown.

Includes 2

cable clips and

a standard

microphone

windshield.

Model shown: Nanocomm 2GA version 2. Shown as

standard with standard 128 mm microphone boom

length, non-filtered custom earmoulds, general

aviation plugs, 2 included cable clips, a standard

microphone windshield and does not include any

optional extras.

Microphone

Red dot

Green dot

-10 dB

Amplified electron-ic noise reduction microphone

Speaker

Max Volume

Min Volume

-22 dB

H=31; M=25; L=24 SNR=29

ProtectHear, Vented (Filtered) 90-OP Custom Moulded

Frequency (Hz)

Mean Attenuation (dB)

Standard Deviation (dB)

Assumed Protection (dB)

63

24.3

5.5

18.8

125

25.6

4.8

20.7

250

25.4

2.5

23.0

500

26.7

4.1

22.6

1000

27.2

2.9

24.3

2000

35.4

2.6

32.7

4000

40.8

4.6

36.2

8000

38.4

5.1

33.2

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EzeFit 2.0 Earpiece

An anatomically shaped generic NanoComm earpiece from Puretone.

We have improved the design of the EzEFIT by adding a friction collar, this advancement ensures that the

microphone stays in its position. The comfortable and secure earpieces can be used as an alternative to a

custom earmould. The black concha lock is made by “EarPro” from soft silicone and is available in small and

large sizes.

Full Earpiece Kit:Large Left Earpiece:Large Right Earpiece:Medium Left Earpiece:Medium Right Earpiece:

The EzEFIT2.0’s shaped barbed adaptor follows the

bend of the ear canal, this allows the user to fit either

large, medium or small domed soft silicone ear tips,

providing a secure seal in the ear for good

attenuation while still allowing for sound to be

transferred into the ear from the headset for clear

communications.

Available as either a kit which includes 2 barbed

adapters, large earpices and small earpieces or as

individual earpieces.

NanoComm Earpiece

Custom-made filtered earmoulds that can be worn comfortably for many hours.

Clear, transparant earmoulds for use with nanocomm headsets.

Boom guides on the mould face keep the boom position by the tragus for a secure fit.

Product Code: ACC146P

NC-GT-KITNC-GT-LLNC-GT-LRNC-GT-MLNC-GT-MR

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ProtectHear Earpiece

ProtectHear ear plugs are CE marked, personally moulded reusable ear protection. EN 352-2: 1993. Tested by Salford

University School of Acoustics. Report No. HP/01/26 & HP/01/27. Certified By Inspec International Ltd, certificate no.

965. ProtectHear have been developed through user-feedback and more than 10 years’ experience of working with-

in the hearing industry.

Product Code: ACC146S

ProtectHear inserts are custom moulded

soft silicone earpieces, individually crafted

under the strictest conditions from an exact

impression of the user’s ears. Each pair are

custom-manufactured using specially formulated

medical-grade silicone, to offer the highest degree

of comfort whilst providing a highly effective acoustic

barrier.

ProtectHear ear plugs are vented and incorporate

a passive acoustic filter, which attenuates loud noises

whilst maintaining the ability of the individual to hear

speech, ambient noise and to use telephones and

radios. Excessive background noise is reduced,

resulting in increased safety and working comfort.

Description: ProtectHear®, Vented (Filtered) 90-OP Custom MouldedFrequency 63 125 250 500 1000 2000 4000 8000Mean Attenuation (dB) 24.3 25.6 25.4 26.7 27.2 35.4 40.8 38.4Standard Deviation (dB) 5.5 4.8 2.5 4.1 2.9 2.6 4.6 5.1Assumed Protection (dB) 18.8 20.7 23.0 22.6 24.3 32.7 36.2 33.2

H=31; M=25; L=24 SNR=29 Frequency (Hz)

Page 26: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

EARGENE ®SOOTHING & REFRESHING

EAR LOTIONRelieves itching ears, softens calcified tissue, softens ear wax and rebuilds keratin layer in the ear canal.

Page 27: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

The Puretone Partnership has many new features, including interactive search functions, filters, graphic maps and directions, all designed to help you find the most suitable dispenser/reseller in your area.

www.puretone.net/retail-outletsTo sign up now, or for more information, please visit

Page 28: Communication - Puretone Ltd · Wireless & Covert Earpieces Covert Communication. The anatomical design of these earpieces allows them to fit comfortably and securely in the ear canal,

9-10 Henley Business Park, Trident Close, Medway City Estate,

Rochester Kent, ME2 4FR. UK.

T: +44 (0) 1634 719427F: +44 (0) 1634 719450E: [email protected]: www.puretone.net

Version 1.0.0 February 2019

An Extensive Range Of Communications Devices To Cater For Every Criteria.

British manufacturers of quality hearing protection plugs, hearing aids, tinnitus management systems, in-ear monitors for musicians,

earmoulds, swimplugs, and covert equipment for surveillance purposes. Suppliers of audiological, ERA equipment and

accessories.

ISO 13485:2003MDD93/42/EEC