Review team The team contributing to this review included: Ms Gretchen Young Young Futures Dr Tegan Keogh Hear Check Ms Shirley Glennon Shirley Glennon Consulting Revisions to the Review of Newborn Hearing Screening and Associated Screening Devices This Review of Newborn Hearing Screening and Associated Screening Devices was first released in March 2014. Following the report’s release it was identified that a number of corrections and revisions needed to be made. This is a revised version of the report that includes corrections and revisions. Details of the corrections and revisions are available on the New Zealand Ministry of Health website at The corrections and revisions do not impact on the report’s conclusions or the recommendations made by Young Futures to the New Zealand Ministry of Health.
List of figures Figure 1. UNHSEIP well-baby newborn hearing screening regime. 60 Figure 2. Comparison of screening and audiology (NZ$) per 1,000 infants screened with AOAE, A-ABR/A-ABR and A-ABR/A-ABR with and without consumables. 86 Figure F1. Comparison of screening and audiology costs (NZ$) per 1,000 infants screened with AOAE, A-ABR/A-ABR and A-ABR/A-ABR with and without consumables. 138 List of tables
evidence indicates that false-positive hearing screen results do not cause general parental anxiety and that mothers who have the knowledge base to understand the context of a refer result experience much less anxiety. DPOAE screening DPOAEs are used less frequently than TEOAEs in newborn hearing screening. Although DPOAEs span a greater frequency range and are generally more robust in the presence of electrophysiological noise, there are problems in specifying a universally acceptable pass/refer criteria for the screen. A single study identifies a pass/fail criteria, with little identifiable data in the area since. While some evidence suggests that DPOAEs have a pass rate of 77.4%, other research has found false-positive rates ranging from 11.0% to 35.0%. One study reported implications for both the cost of consumables required for AOAE screening and parental anxiety. The reason that DPOAEs are not widely implemented is the unavailability of research data specifying the pass criteria to be utilised. Variability in pass and refer rates with differing pass criteria indicates the need for standardisation, particularly when implemented in newborn hearing screening programmes. A renowned expert in OAEs noted that DPOAEs are collected over a much wider range of stimulus intensities and a range of stimulus intensity ratios. This strongly affects sensitivity and specificity, so the volume of data on any particular stimulus combination is small. While there is validity in performing DPOAEs, it has been stated that ‘There are no sufficiently well-established criteria for DPOAEs that would allow DPOAEs to replace TEOAEs in Newborn Hearing Screening Programs without significant risk of a change in current specificity and sensitivity’. For this reason, this technique is not ideal for newborn hearing screening programmes until such data is available. The interpretation of DPOAE results for a neonate should include age-related differences in DPOAE pass rates for low-frequency and high-frequency information. Implications for detection of ANSD Detection of ANSD disorders utilising AOAE regimes is not possible. The OAE indicates cochlear function only, at the level of the outer hair cell. The OAE does not assess auditory function beyond the level of the cochlear and for this reason ANSD cannot be detected. Approximately 10.0% of all children diagnosed with a permanent hearing impairment have ANSD, . While NICU admission is a risk term
Table 3. Profile of data management systems of participating international programmesA. Details Programme 1 Programme 2 Programme 3 Programme 4 Programme 5 Programme 7 Programme 8 Programme 9 Access to demographic data? yes yes yes Yes yes yes yes yes Demographic data uploaded electronically or manually input to screening device? manual manual manual manual manual manual manual manual Interface, electronic upload, or manual of demographic data to database? electronic manual interface electronic electronic manual electronic electronic Data from screening device uploaded electronically or manually to database? electronic electronic and manual electronic electronic electronic manual manual electronic and manual Raw files from screening device saved to network and reconciled against database? raw data files saved and reconciled consistently raw data saved and reconciled consistently raw data files saved and reconciled occasionally raw data files saved and reconciled consistently raw data files saved and reconciled occasionally raw data files saved and reconciled consistently Unique identifier? no no yes yes yes yes yes yes Referral to audiology electronic from database or manual? electronic manual manual electronic electronic electronic electronic of data collection? screening, AU, medical, EI, family support screening, AU screening, AU screening, AU, medical, medical, EI screening, AU, medical, EI screening, AU, medical, EI, family support screening, AU, medical, EI screening, AU, medical Number of databases (e.g. district/national; screening/audiology)? 1 2 2 1 2 2 1 1 Primary database web-based and available remotely and in major screening sites? web-based, available remotely and in hospitals available remotely and in hospitals web-based, available remotely and in hospitals available remotely and in hospitals web-based, available remotely and in hospitals not but accessible remotely, although not in hospitals available remotely and in hospitals web-based, available remotely and in hospitals
Frequency of audit of screening and diagnostic data? regular and frequent audits at all levels regular and frequent audits at all levels some auditing, not scheduled and consistent regular and frequent audits at all levels some auditing, not scheduled and consistent regular and frequent audits at all levels regular and frequent audits at all levels regular and frequent audits at all levels Reporting from database meet requirements for reporting against newborn hearing screening KPIs? reports meet all requirements for KPI reporting reports meet some requirements for KPI reporting reports meet some requirements for KPI reporting reports meet all requirements for KPI reporting reports meet most requirements for KPI reporting reports meet all requirements for KPI reporting reports meet all requirements for KPI reporting reports meet all requirements for KPI reporting Key challenges encouraging full use of all database features exploring ways to ensure txt files from devices cannot be edited double of audiology data from ESP to audiology Access database entering data twice – once for hospital and once for database manual entry to Guthrie card, then to pathology, no access to community data by hospitals, different identifier in community and hospitals timely return of diagnostic data implementation of whole programme, inclusion of EI Future developments building modules for related areas, e.g. Indigenous ear health app for audiologists for ease of data entry resolution of issues with standard reports in ESP, e.g. to report first refer rates extend newborn hearing screening / audiology database to meet hospital needs. downloads from equipment to individual screener or device performance make system the database of choice for audiologists to encourage compliance not all hospitals can provide direct access to demographic data A Details of the data system used by Programme 6 were not accessed.
Cost categories and analysis parameters and variations A standard set of notional costs were calculated for five key cost categories: Initial setup costs: office setup, initial training, and equipment purchase (conservatively assuming a five year equipment lifespan). Equipment maintenance costs: annual supplier maintenance, local screener and co-ordinator maintenance – daily, weekly, monthly and annual. Family costs where screening is not completed in hospital: mileage and attendance costs (e.g. parking, babysitting). Direct screening costs: consumables, labour for each screen, additional labour for refer rescreens, co-ordination for refer results, management, additional costs for community screening (assuming 10% community screening rate), tracking of lost to follow-up or referred infants, screener training and competency assessment, additional hearing assessment and therapy for infants not diagnosed with ANSD in the context of a regime using AOAE as the first screen. Diagnostic costs: assessment of false positives (two appointments), assessment of permanent bilateral moderate or greater hearing loss, and other hearing losses (four appointments), data entry and report writing. Data management were not included in the screening estimates due the difficulty of establishing a realistic average cost given the wide variety of data management processes used The parameters for the analysis of notional annual costs are set out below. Annual costs for each regime were based on: full capture of 1,000 eligible well-baby births, use of the same: screening workforce; A-ABR first, second and/or third refer rates; AOAE first, second and/or third refer rates; lost to follow-up rate; and outpatient screening rates, use of consumables, current costs expressed in (NZ$), additional time being allocated to A-ABR screening (30 minutes) compared to AOAE (20 minutes), and
Validation Nil in literature Nil as a combination unit (A-ABR and AOAE). One study for AOAEs, and adults only. Large studies Large studies Large studies Nil Large studies Portable YES YES YES NO YES YES YES Complex capabilities Device has some complexities. Provides automated screening result. Additional features available for purchase (i.e. other assessments / capabilities). Screener device. Provides automated screening result. Requires no interpretation of data. Screener and clinical device. Provides automated screening results. Requires no interpretation of data. Diagnostic options depending on model selected. Screener device. Provides automated screening results requiring no interpretation of data. Screener device. Provides automated screening results requiring no interpretation of data. Screener and clinical device. Provides automated results requiring no interpretation of data for AOAE and Some interpretation required for tympanometry. Screener device. Provides automated screening results requiring no interpretation of data. Power source AC and battery AC and battery AA batteries (screening device) Internal rechargeable battery or power source (laptop or tablet) source required Internal rechargeable battery Internal rechargeable battery Internal rechargeable battery Type of ear cups Disposable ear cups. Disposable ear cups – newborn to BERAphone: Nil Classic: Disposable ear cups Disposable ear cups Disposable ear cups Disposable ear cups Disposable ear cups Screen memory 1,000 records on device 300 records on device Infinite on PC/tablet Infinite on PC 100 on device Infinite on PC 250 on device Warranty 1 year 1 year 1 year 1 year 1 year 1 year 1 year
Sentiero GSI AUDIOscreener MAICO MB 11 BERAphone MAICO MB 11 Classic ALGO 5 ALGO 3i Titan MADSEN AccuScreen Clinical benefits Easy screen to navigate. Binaural screening. Configurable AOAE pass criteria. BERAphone & Classic: Data encryption Upgradeable software Small Light Portable Binaural screening. Algorithm would slow significantly for an adult therefore deter from falsifying records. Upgradeable software. Binaural screening. Hand held, portable device. Algorithm would slow significantly for an adult therefore deter from falsifying records. Upgradeable software. Binaural screening. Full of testing. Possibility to add diagnostic modules and utilise through teleaudiology. Can be A-ABR only. Intuitive touch screen. Slower screen time for an adult. BERAphone: No consumables Classic: Binaural screening Clinical risks specific to the UNHSEIP Not used in any screening programme. Not designed specifically for newborn screening. Not an intuitive screen. BERAphone: Unusual placement on baby’s head – additional training required. Can only screen one ear at a time – risk of using results of one ear as the second ear. Classic: More pieces to in comparison to BERAphone (but still compact) No flexibility for outpatient screening – on large trolley. Complex due to tests. No ear canal volumes on AOAEs. Tympanometry requires interpretation. Not used as a screening device in any other country. No ear canal volumes on AOAE module. Data security. Disadvantages specific to each device No scientific literature. No scientific literature. No upgradeable software. BERAphone: Unusual placement. Classic: Consumable (in contrast to BERAphone). device. Suitable for hospital screening only. Additional training due to larger suite of tests, and inclusion of tympanometry. High complexity. Data security. A Costs are subject to vary and should be used as a guide one.
be validated through peer reviewed studies published in international journals, with appropriate sample size and scientific methodology, have a validated detection algorithm, be user friendly/functional for the screener workforce, minimise ease of falsifying a screen, enable data monitoring and data security, be time effective relative to devices, contribute to cost effective screening outcomes, be portable, be consumer friendly, enable efficient data upload and download, be calibrated to an internationally published reference, have an effective, efficient and flexible computing interface, incorporate comprehensive support, including training, and be compatible with current and future technologies. Recommendation 3 Ensure the following conditions are met to facilitate both a successful change in regime and device, and to optimise the overall effectiveness of the programme: use a nationally managed organisational change process to facilitate implementation of the new regime and introduction of a nationally consistent device, standardise the screening regime, device, clinical practice and protocols nationally, prioritise inpatient screening, including reducing the minimum age of screening, review targeted follow-up criteria,
Screening cost assumptions Table F4. Screening costs. Cost category Measure Comments Screener cost – range Advice from NSU Screener cost – upper range $53,000/annum Advice from NSU Screener cost – average $42,500/annum Screener cost – average/hour including on costs $30/hour Screener on costs 30% Estimate Time/screen – AOAE 0.33 hour Estimate Time additional AOAE refer one step 0.10 hour Estimate Time additional A-ABR refer one step 0.25 hour Estimate Time/screen – A-ABR click 0.50 hour Estimate based on experience with newborn hearing screening Time refer reschedule 0.10 hour Estimate based on experience with newborn hearing screening First refer rate – AOAE 20% Estimate on the range of published first refer rates and data reported through the review of international programmes. First refer rate – A-ABR 7% As above Second refer rate – AOAE 12% As above Second refer rate – A-ABR 0.95% As above
Second rate A-ABR – one stage 5% Based on advice from two DHBs in NZ Second refer follow up 0.33 hour Estimate on programme experience Final refer rate (AOAE/AOAE/A-ABR) 1.52% Estimate based on average referral rates reported by programmes meeting this criteria (international Programme 6 and Programme 7 and the UNHSEIP) Third refer rate (A-ABR/A-ABR/A-ABR) 0.5% Estimate based on diagnostic outcomes from testing following referral from two stage A-ABR where approximately half of the babies referred to audiology have a hearing loss (including conductive losses) Local coordinator/screen 0.02 hour Estimate based on experience with newborn hearing screening Local coordinator/first refer 0.08 hour Estimate based on experience with newborn hearing screening coordinator/second refer 0.50 hour Estimate based on experience with newborn hearing screening Local coordinator including on costs $35/hour Estimate Inpatient screening rate 90% Estimate based on reports from international hospital-based programmes interviewed Dedicated community clinic screening rate – low 10% Estimate based on reports from international hospital-based programs interviewed
Travel – mileage $0.74 Based on 2014 Australian Tax Office mileage rate Travel – kilometres/clinic Based on advice from two DHBs Travel – transport/clinic $148 Based on above two assumptions Travel + setup time/clinic 1.50 Assuming 30 minutes travel each way and 15 minutes setup and pack up Community clinic – babies/clinic 10 babies Estimate on advice from two DHBs Community clinic – lost to follow-up rate, reschedule 20% Estimate based on advice from two DHBs Did Not Attend rate/1,000 births 15% Based on UNHSEIP Monitoring Report Did Not Attend follow-up time tracking/baby 0.20 hours Estimate based on experience with newborn hearing screening Labour – DHBs time 5 hours/month Estimate based on experience with newborn hearing screening Estimate DHB costs $35 Estimate Labour – corporate 2.0 FTE Estimate Labour – corporate average hourly rate including on costs $50 Estimate Labour – corporate infants $3,310 Estimate Labour – estimated national data input, 1.0 FTE including on costs $54,925 Estimate Labour – estimated data analysis, 0.4 FTE including on costs $43,062 Estimate
Audiology – rate of false positives: AOAE 11.8% Estimate based on 1) detection of permanent HL at diagnosis and 2) a range of reported referral to audiology rates from AOAE programs Audiology – rate of false positives: A-ABR 0.8% Estimate based on 1) detection of permanent HL at diagnosis and 2) a range of reported referral to audiology rates from programs Audiology – rate of false positives: A-ABR one step 3.8% Estimate based on 1) detection of permanent HL at diagnosis and 2) advice re referral rates from the AOAE/A-ABR stage of the AOAE, A-ABR/A-ABR regime Audiology – rate of false positives: A-ABR three step 0.3% Estimate based on 1) detection of permanent hearing loss at diagnosis and 2) estimate of referral rate to audiology from three stage A-ABR regime Audiology – rate false positives AOAE/A-ABR 1.4% Estimate based on 1) detection of permanent hearing loss at diagnosis and 2) estimate of referral rate to audiology from two stage AOAE/A-ABR Audiology rate false positives – where A-ABR is the last of three screens 1.3% Estimate based on 1) detection of permanent HL at diagnosis and 2) average referral rates where A-ABR is the last of three screens. Audiology – cost including on costs $76/hour Estimate Audiology – number of appointments/diagnosis of target condition 4 Estimate based on experience with newborn hearing screening Audiology – rate of target condition 0.1% Estimates based on reported rates in literature and review of international programmes Audiology – rate of other hearing loss 0.1% Estimate based on reported rates in literature and review of international programmes
Audiology – data false positive 16 minutes Estimate based on experience with newborn hearing screening Audiology – data entry: diagnosis of target condition 33 minutes Estimate based on experience with newborn hearing screening Data management assumptions F6. Data management costs. Cost category Measures Comments Data manager: cost $30/hour Estimate based on experience with newborn hearing screening Data – demographics: manual upload partial 0.02 hours/baby Estimate based on experience with newborn hearing screening Data – demographics: manual upload full 0.03 hours/baby Estimate based on experience with newborn hearing screening Data – demographics: auto upload 0.08 hours/upload Estimate based on experience with newborn hearing screening Data – screen: manual upload: child 0.03 hours/baby Estimate on experience with newborn hearing screening Data – screen: auto upload 0.1 hours/day Estimate based on experience with newborn hearing screening Data management – first refer: database 0.05 hours/1st refer Estimate based on experience with newborn hearing screening Data management – second refer: database 0.03 hours/2nd refer Estimate on experience with newborn hearing screening Data management – first refer: manual 0.08 hours/1st refer Estimate based on experience with newborn hearing screening Data management – second manual 0.16 hours/2nd refer Estimate based on experience with newborn hearing screening Assumed number of births/upload 30/upload Estimate