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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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 2 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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 3 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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 4 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft 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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 5 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft 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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 6 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft 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 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 7 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft 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. DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 8 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft 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 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 9 DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft DRAFT Revised Schedule 3 – Device Specifications Version: October 2013 Consultation Draft Page 10