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Newborn hearing screening, diagnosis and intervention. Ferdinando Grandori Istituto di Ingegneria Biomedica – Consiglio nazionale delle Ricerche ARSI-Onlus (Associazione Ricerca Sordità Infantile). Lo screening audiologico neonatale Brescia, 20 novembre 2004. CNR ISIB. The EHDI system.
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Newborn hearing screening, diagnosis and intervention Ferdinando Grandori Istituto di Ingegneria Biomedica – Consiglio nazionale delle Ricerche ARSI-Onlus (Associazione Ricerca Sordità Infantile) Lo screening audiologico neonatale Brescia, 20 novembre 2004 CNR ISIB
The EHDI system SCREENING < 1 MONTH ASSESSEMENT < 3 MONTH INTERVENTION < 6 MONTH
The EHDI system Birthing Hospital Audiology Parent Groups Primary care provider baby/family Deaf associations ENT Services for Hearing Loss Genetics Early Intervention Programs
EHDI programmesin the European area_________________________________________________________________ WHY • All available results (scientific and clinical) point out that the earlier the intervention the better the outcomes. • EHDI systems are becoming the standard of care worldwide
Early Hearing Detection and Intervention Programs • European area • USA • Worldwide
Early Hearing Detection and Intervention Programs • European area • USA • Worldwide
EHDI programmesin the European area_________________________________________________________________ • Universal hearing screening is mandated - or supported - by central health authorities, in a number countries, or regions: Austria, Belgium (Flanders), Croatia, England, Lithuania, Luxembourg, Netherlands, Poland, laenders in Germany, a number of Regions in Italy and Spain.
Estimates of Number of Hospitals doing Universal Newborn Hearing Screening in the EU Number of Programs (AHEAD II, July ‘04)
EHDI programmesin the European area_________________________________________________________________
EHDI programmesin the European area_________________________________________________________________
EHDI programmesin the European area_________________________________________________________________
Early Hearing Detection and Intervention Programs • European area • USA • Worldwide
2004 State EHDI Survey NCHAM National Ctr for Hearing Assessment and Management During the first quarter of 2004, state Early Hearing Detection and Intervention (EHDI) coordinators were asked to complete a survey about their program (Source: www.Infanthearing.org by courtesy of Dr. Karl White)
SCREENING (1) • Percentage of babies born (3rd quarter 2003) in your state screened before leaving the hospital? • 89.72% of all babies being screened • 91.62% excluding states ≤ 80% (CA, IA & OH) • Birthing facilities • Total: 3602 • Minimum: 7 (RI) • Maximum: 350 (CA) (courtesy of Dr. Karl White)
SCREENING (2) • Birthing facilities doing UNHS (i.e., > 90% of all births) at the end of December 2003 • Total: 3120 • Range: 6 – 263 • Weighted percentages: • 86.62% of all birthing facilities doing UNHS • 90.88% excluding states ≤ 80% (CA, KS, NY, TN, & WA) (courtesy of Dr. Karl White)
SCREENING (3) hearing screening –surveillance- occurs for: (courtesy of Dr. Karl White)
REFERRALS • Percentage of the referrals • 5.57% - 47 States responding • 3.52% - Excluding outliers • ≤ 1% (10 states) and • > 10% (3 states) • No response or "unknown": 4 states (courtesy of Dr. Karl White)
DIAGNOSIS • Hearing status confirmed by 3 months of age • 55.09% 36 states responding • 53.80% Excluding outliers ≤ 5% (3 states) and ≥ 90% (5 states) • No response or "unknown": 15 states (courtesy of Dr. Karl White)
EARLY INTERVENTION % who began appropriate early intervention by 6 months of age: 48.68 % who began appropriate early intervention after 6 months of age: 19.66 % for which early intervention status is unknown 32.19 (No response: 15 states) N.B.: % of those identified with permanent hearing loss, but not all those who didn’t pass the screening have been diagnosed! (courtesy of Dr. Karl White)
EVALUATION • State certifying, licensing, or approving hospital-based programs • Hospital conducting UNHS: • YES 11 NO 40 • Individuals doing screening: • YES 7 NO 44 (courtesy of Dr. Karl White)
Early Hearing Detection and Intervention Programs • European area • USA • Worldwide
Argentina FEW Armenia ATTEMPTS Australia +++PI Brazil FEW Bulgaria ATTEMPTS Canada +++PI China +FEW Cuba ++PI India ATTEMPTS Indonesia ATTEMPTS Israel ++++I
Japan +++PI Jordan ATTEMPTS Mexico ATTEMPTS N. Zealand +PI Palestinian Authority ATTEMPTS Russia +FEW Serbia&Montenegro ATTEMPTS Singapore +FEW South Africa +FEW South Korea ATTEMPTS Turkey +FEW
Early Hearing Detection and Intervention Programs are becoming the standard of care in an increasing number of countries • Screening models have been receiving much attention during the past decade BUT still there is a long way to go for protocols and minimum requirements
ECDC- NHSMilan, 15 - 16 May 1998 European Commission Biomedicine and Health Programme Project AHEAD
Advancement of HEaring Assessment methods and Devices – Immediate InterventionEuropean CommissionQuality of Life Programme(QLG5-2000-01613)www.biomed.polimi.it/AHEADII
www.NHS2006.polimi.it NHS@polimi.it ccccccccccccccc
THE PERIPHERAL AUDITORY SYSTEM 1 pinna 2 auditory canal 3 tympanic membrane 4 ossicles 5 cochlea 6 VIIIth nerve
OAE-based Screening Protocols 1- or 2-AOAE test pass fail STOP AABR test fail pass REFER STOP
ABR-based Screening Protocols AABR test pass fail REFER STOP
EHDI programmesin the European area_________________________________________________________________ HOW THE OPTIMAL MODEL FOR UNIVERSAL NEWBORN HEARING SCREENING DOES NOT EXIST
Critical issues - Protocols_________________________________________________________________ Properties of an ideal screening device: • Robust and reliable automatic detection algorithm • Built-in automatic calibration (to control stimulus levels) for both AAOEs and AABR • Maximum flexibility to cope with the variety of screening conditions: mother-side, nursery, NICU…. • Insensitivity to background noise • Maximum flexibility to cope with the changing screening criteria (standards are expected soon…)
Screening Protocols_________________________________________________________________ A two-track protocol? • At-risk (NICU)(*): AABR-based • Well-babies: • 1 or 2-stage AOAEs+AABR • 1-stage AABR (*) the incidence of PHL can be as high as 4 to 6%: is this “screening”??
COMBINING AOAE+AABR • Calibration of acoustic stimuli in the canal • Lower referrals and false-positives • Minimal parental anxiety • Fewer diagnostic tests • Fewer babies are lost • More efficient management • Auditory neuropathy can be identified early
AOAE pass fail STOP AABR fail pass STOP REFER 3rd GENERATION AOAE+AABR DEVICES
EHDI programmesin the European area_________________________________________________________________
EHDI programmesin the European area_________________________________________________________________
EHDI programmesin the European area_________________________________________________________________
POLAND (2001-2003): • 440 birthing units • 44 audiological ctrs • 7 IIIrd level audiological ctrs Warsaw, Jan. 11, 2001 Warsaw, Jan. 11, 2002
Dr. Zelika Antunović, vice-President of Croatia CROATIAN EHDI Program Zagreb, Sett. 12, 2002
Advocating for Universal Screening with the Italian Minister of Health (Dec. 2003)
LOMBARDIA • ISTAT 1995 (Italy): • 1,6 per 1000 severely impaired (>70dB) • 15,2 per 100 total population (incl mild) • INCIDENCE AT BIRTH: ~ 1.5 per 1000 • LOMBARDIA (~ 9 ml) • 136.800 hypoacusia (mono- and bilateral) • 14.400 severe to profound • ~ 90.000 newborn/yr • ~ 90 - 180 new cases/yr
REGIONE LOMBARDIADIREZIONE GENERALE SANITA’NETWORK SORDITA’(giugno 2003) Identificazione, diagnosi e trattamento precoce sordità infantile (0-6 anni) Maternità, Centri audiologia di 1o, 2o e 3o livello
(1998) A SUCCESSFUL UNIVERSAL NEWBORN HEARING SCREENING PROGRAM (Milan Program) P. Ravazzani1, G. Pastorino2, P. Sergi2, G. Tognola1, F. Grandori1, A. Marini3 1Centro di Ingegneria Biomedica CNR, Milano 2Clinica Mangiagalli, Servizio di Neurofisiopatologia, ICP, Milano 3Divisione di Neonatologia, IaClinica Pediatrica dell'Università di Milano
ARSI-OnlusFondata nell’anno 2000, ha devoluto più di 360,000 Euro per la realizzazione di programmi di screening universali (apparecchiature, training, formazione permanente, materiale didattico e divulgativo, ecc)Finanziatoriprivati, aziende del settore audiologico, aziende eletromedicali, Fondazioni