Download Consultation Draft Revised Minimum Device Specifications

DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation draft
AUSTRALIAN GOVERNMENT
HEARING SERVICES PROGRAM
DEED OF STANDING OFFER
X Month 20XX – X Month 20XX
DRAFT ONLY
Schedule 3 – Device specifications
DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft
SCHEDULE 3 – DEVICE SPECIFICATIONS
1.
INTRODUCTION
1.1
Device specifications are written with the understanding that there are a number of
considerations that must be addressed when selecting and fitting a device to an
individual Client.
1.2
The manufacturer will be responsible for ensuring the device meets the required
Deed specifications.
1.3
Alternative technologies that achieve an equivalent benefit to clients may be
submitted to the Office of Hearing Services for consideration. Devices with new or
innovative features, which could include upgradeable technology for existing
device shells, will be considered for listing on the schedule upon provision of
evidence in support of potential client benefits. Evidence could take the form of
field trial data, other test results, validated research.
2.
MINIMUM SPECIFICATIONS FOR DEVICES
2.1
All electroacoustic measurements referred to in this specification are to be
made in a 2cc coupler conforming to Australian Standard AS1089-1971, or
IEC Publication 126, but otherwise in accordance with the Australian Standard
AS 1088 (equivalent to IEC 60 118).
HEARING DEVICE DESIGN
All devices supplied must be of solid construction and reliable in their operation.
The battery compartment must be easy to open and the battery must be easy to replace,
unless the battery is rechargeable. If necessary, a tool should be provided to assist with
both functions.
If the on/off switch is incorporated into the battery holder it must operate without allowing
the battery to fall out of the device.
An effective wax management system must be made available for custom and receiver in
the canal devices.
STABILITY
Response peaks which are due to positive feedback must not deviate by more than 2 dB
from a response obtained at lower gain settings which have no evidence of feedback, as
measured in a standard (HA1 or HA 2) 2cc coupler.
FREQUENCY RESPONSE
Manufacturers are encouraged to provide hearing aids with the widest bandwidth feasible
and which have adjustable gain throughout the useable bandwidth.
To enable the aid to be customised for the individual Client, it must be possible for the fitter
to vary the gain independently at four or more frequencies, spaced adequately.
With all tone controls set for maximum gain, the peak to trough ratio for both the gain and
MPO curves must be less than 7 dB. Peak to trough is defined as the decibel difference
between a trough and the straight line joining the two peaks immediately surrounding the
trough.
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DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft
OSPL90
Each device must have a means by which the fitter can adjust OSPL90 so that it produces
adequate loudness sensation for Clients while minimising loudness discomfort. The device
design must be such that loudness discomfort can be minimised for any setting of the
(manual or automatic) volume control. This will normally require that OSPL90 be
unaffected by the volume control setting. (It is, however, permissible for the apparent
OSPL90, measured with a 90 dB SPL input signal, to decrease when the volume control
setting is reduced sufficiently to cause the output signal to be insufficient to saturate the
device).
The range of adjustment of any OSPL90 control, averaged over the range of frequencies
that it is intended to control, must be a minimum of 10 dB.
GAIN/COMPRESSION
Devices must include compression that enables the long-term dynamic range of speech to
be reduced by different amounts at three or more frequencies.
There must be the capability to separately adjust, in each channel, the gain for low
(50 dB SPL or lower) and high (80 dB SPL or higher) input levels (or equivalently,
the compression ratio and overall gain) to produce compression in at least the range
of 1:1 to 3:1.
DISTORTION
Total Harmonic Distortion must not exceed the values in Table 1.
When testing the device all controls must be set to the position that leads to the flattest
frequency response. The gain must be set to the reference test gain in accordance with
IEC 60 118-0.
Table 1. Total Harmonic Distortion for devices
Frequency (Hz)
Input Level
(dB SPL)
500 Hz
800 Hz
1600 Hz
65
90
5%
20%
5%
15%
5%
10%
The distortion figures in Table 1 are not to be exceeded for any setting of the OSPL90
control. When an OSPL90 control is set to give an OSPL90 greater than 112 dB SPL for
an ITE or ITC device, or greater than 128 dB SPL for a BTE device, testing with a 90 dB
SPL input level is not required for these OSPL90 settings. Note however, that testing at 90
dB SPL is still required when the OSPL90 of these devices is reduced below these 112 and
128 dB SPL limits.
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DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft
NOISE
Equivalent Input Noise must not exceed the values shown in Table 2.
The measurements must be made in accordance with IEC 60 118-0 paragraph 7.14.2 with
the gain and OSPL90 set to maximum and the volume control set to a gain 10 dB below
maximum.
Table 2. Maximum 1/3 octave input referred noise
Freq Hz
Noise (dB SPL)
OSPL90>128dB SPL
250
500
1000
2000
4000
(a)
38
30
20
23
26
Noise (dB SPL)
all other devices
(b)
37.5
26.5
17.5
14.5
16.5
The figures shown must not be exceeded when any control which alters the
device's response is adjusted to reduce gain at 500 Hz by 10 dB.
ELECTRICAL (AUDIO) INPUT
Devices with an OSPL90 greater than 128 dB SPL must have the facility to connect audio
signals into the device, either by a direct electrical input or by wireless.
Devices with an electrical input must conform to IEC 60 118-6.
TELECOIL
An effective telecoil and means for enabling the telecoil must be available free of charge
on all approved devices including Top-Up devices. Low gain devices without telecoil may
be approved if they offer sufficient other advantages to compensate for the absence of a
telecoil and which result in a design incompatible with the inclusion of a telecoil.
It must be possible to configure the device so that at the reference volume control position,
and with the device oriented for maximum sensitivity, the output SPL of the device for a
31.5 mA/m magnetic input at 1.6 kHz is within + 5 dB of the output of the device with an
acoustic input of 60 dB SPL. That is, the relative simulated equivalent telephone sensitivity
(RSETS; IEC 60 118-0) value must be within the range + 5 dB.
USER CONTROLS
Devices must contain a manual volume control, an automatic volume control, or be
provided with a remote volume control. It is acceptable for a manufacturer to offer devices
with no volume control, provided the manufacturer also supplies devices with equivalent
performance and which have a volume control.
A user operated control, if present, must be easy to operate.
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3.
REQUIREMENTS FOR SOUND DELIVERY AND
RETENTION SYSTEMS
3.1
Devices can be fitted with a custom ear mould or ear shell, or can be fitted with
pre-formed tubing and ear canal fittings, provided the latter securely retains the
hearing device on the head.
EAR MOULDS AND SHELLS
Ear moulds/shells must be accurately manufactured from individual ear impressions.
Ear moulds/shells must be fully cured with a smooth finish free of blemishes.
Ear moulds/shells must be durable and able to withstand daily use by Clients.
There must be provision for appropriate attachment of the ear mould/shell to the
remainder of the device in a secure way.
I.
II.
For BTE devices, tubing must be securely fixed to the ear mould.
For ITE, ITC and CIC devices, the shell must be firmly attached and
merge smoothly with the remainder of the device.
The wall areas of the ear mould/shell must be of sufficient thickness for ITEs and ITCs to
prevent holes being worn in the shell through regular use and to allow for mould
modifications.
Appropriate venting and plumbing options must be available.
A range of ear mould styles and materials must be available to meet individual needs and
particularly to overcome any allergic reactions a Client may have to a particular
material.
Ear moulds and shells must not be made of a material that changes size or shape
significantly over time.
Ear moulds for BTE devices must be clear or of suitable skin coloured tint unless
otherwise requested.
OTHER SOUND DELIVERY AND RETENTION SYSTEMS
Capillary tubing and dome tips used with devices must be durable and able to withstand
daily use by clients. Tubing must be easily replaceable.
All non-customised sound delivery and retention systems must provide comfort, retention
and control of feedback that is equivalent to that which can be obtained from a custom
device.
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4.
REQUIREMENTS FOR FREE-TO-CLIENT DEVICES
4.1
Free-to-client devices provided under the Hearing Services Program must meet the
requirements set out in Table 3.
Table 3: FREE-TO-CLIENT DEVICES
1. Minimum specifications
AND
2. All of the following:



Automatic directional microphone (except ITC and CIC devices)
Adaptive noise reduction
Feedback cancellation
AND
3. At least one of the following:














Transient noise reduction
Autophone
Adaptive directional microphone
Automatic environmental adaptation
Wireless connectivity
Super directional microphone
Frequency transposition/compression
Trainability/environmental learning
Bilateral synchronisation
Bilateral audio-processing
Tinnitus sound generator
Rechargeable battery
Remote control
Maximum output greater than 128dB SPL at 1600 H
NOTE:


CIC is defined as a Completely-in-Canal style device which has a faceplate that sits at the ear
canal entrance. This device may be listed as Free-to-Client or Top-up.
A 2 year warranty period will be considered for inclusion as a minimum specification under the
next specification review.
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5.
REQUIREMENTS FOR TOP-UP DEVICES
5.1
Top-up devices must meet the same requirements as Free-to-Client devices and also
include three additional features (capable of operating simultaneously) from
amongst those listed in Table 4.
Top-up features have been identified as providing clinical benefits over and above
what is required to achieve an acceptable standard of rehabilitation as specified in
the Hearing Services Rules of Conduct 20121.
5.2
Table 4: TOP-UP DEVICES
1. Minimum specifications
AND
2. All of the following:



Automatic directional microphone (except ITC and CIC devices)
Adaptive noise reduction
Feedback cancellation
AND
3. At least THREE of the following, capable of operating simultaneously:














1
Transient noise reduction
Autophone
Adaptive directional microphone
Automatic environmental adaptation
Wireless connectivity
Super directional microphone
Frequency transposition/compression
Trainability/environmental learning
Bilateral synchronisation
Bilateral audio-processing
Tinnitus sound generator
Rechargeable battery
Remote control
Maximum output greater than 128dB SPL at 1600 Hz
http://www.comlaw.gov.au/Details/F2012L01149
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6.
REQUIREMENTS FOR NON-STANDARD DEVICES
6.1
A Non-Standard Device is a Device that has special application to particular clinical
requirements which may not be able to be met using a standard hearing device such
as a BTE or ITE.
6.2
Types of Non-Standard Devices that are listed on the Free-to-Client Schedule
include:
a) Body-worn hearing aids
b) Spectacle aids
c) CROS, BICROS, STEREO CROS and Wireless CROS aids
d) Bone Conduction aids
e) Assistive Listening Devices (ALDs) provided as an alternative to standard
hearing devices.
6.3
The performance of these Non-Standard Devices will be assessed taking into
consideration the clinical use for which they are intended and any relevant
performance specifications for Free-to-Client Devices.
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7.
DEFINITIONS OF FEATURES
FEATURE
DEFINITION
Device
A self-contained electronic instrument, of which no part is
surgically implantable, specifically designed and manufactured
to provide amplification to individuals with a hearing loss.
(This definition is an addendum to the definition of “Device” in other parts of the Deed).
Adaptive noise reduction
A method of automatically changing the gain-frequency response,
either quickly or slowly, in a manner dependent on the variation
of SNR across frequency, and that causes the overall SNR to
increase.
Feedback cancellation
A method of reducing susceptibility to feedback oscillation that
results in substantially no gain reduction.
Transient noise reduction
A method of automatically changing gain, or gain-frequency
response to provide reduction of intense transient sounds without
affecting succeeding sounds.
Autophone
A feature which switches the device input automatically to a
telephone signal when appropriate.
Automatic directional
microphone
A microphone that can automatically change between directional
and omni-directional when appropriate.
Adaptive directional
microphone
A directional microphone whose directivity pattern automatically
varies so as to maximise the ratio of sensitivity to frontal sources
relative to other sources.
Automatic environmental
adaptation
A device whose output adapts to the environment by varying
amplification parameters other than those associated with
wide-dynamic range compression.
Wireless connectivity
The capacity of a device to facilitate wireless connectivity to
external compatible devices.
Super directional
microphone
A directional microphone whose directivity index (the ratio of
sensitivity for frontal sounds relative to all other directions) is
greater than 6.0 dB.
Frequency
transposition/compression
The downward compressing and/or shifting of output frequencies
so as to substantially increase audibility of high frequency sounds.
Trainability/environment
al learning
Devices that automatically adjust signal processing parameters to
user preferences in different listening environments by applying
user input over time.
Bilateral synchronisation
A wireless communication between two devices that enables the
exchange of environmental information to synchronise automatic
and user-controlled signal processing variables that affect the
device output.
Bilateral audio processing
A wireless communication between two devices that enables at
least one device to combine or select audio signals from both
sides of the head.
Rechargeable batteries
Batteries that are able to be recharged by the user without
removal of the battery from the Device.
Generation of sound with adjustable characteristics intended to
alleviate tinnitus.
Tinnitus sound generator
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