A1260011715HgcdK

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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
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The EHDI system

SCREENING lt 1 MONTH

ASSESSEMENT lt 3 MONTH

INTERVENTION lt 6 MONTH
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The EHDI system
Birthing Hospital
Parent Groups
Audiology

Primary care provider baby/family

Deaf associations
ENT
Services for Hearing Loss
Genetics
Early Intervention Programs
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 EHDI programmes in 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

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• Early Hearing Detection
• and Intervention Programs
• European area
• USA
• Worldwide

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• Early Hearing Detection
• and Intervention Programs
• European area
• USA
• Worldwide

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 EHDI programmes in 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.

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Estimates of Number of Hospitals doing Universal
Newborn Hearing Screening in the EU
Number of Programs
(AHEAD II, July 04)
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 EHDI programmes in the European
area_____________________________________________
____________________
AUSTRIA I Basically in all hospitals (a few in Wien) estimated coverage 80 to 85
BELGIUM (Flamish) I coverage gt99
BELGIUM (French) - UNHS under discussion at the Ministry of Health (Dec. 2003)
CROATIA I Mandatory, coverage gt90
CZECH REP. - Voluntary, impl. at a few hospitals
DENMARK PL UNHS is being financed (Spring 2004)
FINLAND - Voluntary, a few hospitals
FRANCE PL The Ministry of Health, Family and Disabled has financed a pilot (Dec. 2003)
GERMANY PI UNHS in a number of laenders

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 EHDI programmes in the European
area_____________________________________________
____________________
GREECE - 15 hospitals
HUNGARY - UNHS in a number of hospitals
ITALY PL 7 Regions out of 20 ( 25)
IRELAND - At a few hospitals
LITHUANIA PL coverage 50
LUXEMBOURG I gt99
NETHERLANDS I gt95
NORWAY - Pilots in a number of hospitals
MALTA PI 3 hospitals

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 EHDI programmes in the European
area_____________________________________________
____________________
POLAND I Above 90 (April 04)
PORTUGAL - Voluntary at 2 to 3 hospitals
ROMANIA PL Voluntary, at a few hospitals
SPAIN PI Supported in many Health Regions (overall 35 to 40)
SLOVACK REP. PL Voluntary, at a few hospitals
SLOVENIA PL Implemented at a number of hospitals
SWEDEN PI In a number of Counties
SWITZERLAND PI Implemented in the majority of the hospitals (60 to 65)
UK - ENGLAND I Coverage 90 (May 04)

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• Early Hearing Detection
• and Intervention Programs
• European area
• USA
• Worldwide

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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)
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• 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)
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• SCREENING (2)
• Birthing facilities doing UNHS (i.e., gt 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)
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SCREENING (3) hearing screening surveillance-
occurs for
states states
YES NO
Preschool aged children 2 49
Children in grades 1-3 0 51
(courtesy of Dr. Karl White)
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• REFERRALS
• Percentage of the referrals
• 5.57 - 47 States responding
• 3.52 - Excluding outliers
• 1 (10 states) and
• gt 10 (3 states)
• No response or "unknown" 4 states

(courtesy of Dr. Karl White)
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• 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)
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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 didnt pass the screening have been diagnosed!
(courtesy of Dr. Karl White)
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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)
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• Early Hearing Detection
• and Intervention Programs
• European area
• USA
• Worldwide

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Argentina FEW Armenia ATTEMPTS Australia
PI Brazil FEW Bulgaria ATTEMPTS Canada
PI China FEW Cuba
PI India ATTEMPTS Indonesia
ATTEMPTS Israel I
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Japan PI Jordan ATTEMPTS Mexico
ATTEMPTS N. Zealand PI Palestinian
Authority ATTEMPTS Russia FEW SerbiaMontene
gro ATTEMPTS Singapore FEW South Africa
FEW South Korea ATTEMPTS Turkey FEW
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• 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

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ECDC- NHS Milan, 15 - 16
May 1998 European Commission Biomedicine and
Health Programme Project AHEAD
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Advancement of HEaring Assessment methods and
Devices Immediate InterventionEuropean
CommissionQuality of Life Programme(QLG5-2000-01
613) www.biomed.polimi.it/AHEADII
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www.NHS2006.polimi.it NHS_at_polimi.it
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NHS Conferences
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THE PERIPHERAL AUDITORY SYSTEM
1 pinna 2 auditory canal 3 tympanic membrane 4
ossicles 5 cochlea 6 VIIIth nerve
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OAE-based Screening Protocols
1- or 2-AOAE test
pass

fail
STOP
AABR test
fail
pass
REFER
STOP
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ABR-based Screening Protocols

AABR test
pass
fail
REFER
STOP
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 EHDI programmes in the European
area_____________________________________________
____________________
HOW THE OPTIMAL MODEL FOR UNIVERSAL NEWBORN
HEARING SCREENING DOES NOT EXIST

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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)

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Screening Protocols ______________________________
___________________________________

• A two-track protocol?
• At-risk (NICU)() AABR-based
• Well-babies
• 1 or 2-stage AOAEsAABR
• 1-stage AABR
• () the incidence of PHL can be as high as 4 to
  6 is this screening??

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COMBINING AOAEAABR

• 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

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AOAE
pass

fail
STOP
AABR
fail
pass
STOP
REFER
3rd GENERATION AOAEAABR DEVICES
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 EHDI programmes in the European
area_____________________________________________
____________________
AUSTRIA I Basically in all hospitals (a few in Wien) estimated coverage gt80 to 85
BELGIUM (French) - UNHS under discussion at the Ministry of Health (Dec. 2003)
BELGIUM (Flamish) I coverage gt99
CROATIA I Mandatory, coverage gt90
CZECH REP. - Voluntary, impl. at a few hospitals
DENMARK PL A planning committee on UNHS has established (2003)
FINLAND - Voluntary, a few hospitals
FRANCE PL The Ministry of Health, Family and Disabled has financed a pilot (Dec. 03)
GERMANY - UNHS in a few laenders low coverage almost everywhere

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 EHDI programmes in the European
area_____________________________________________
____________________
GREECE - 10 hospitals
HUNGARY - A number of hospitals
ITALY PL 7 Regions out of 20 ( 25)
IRELAND - At a few hospitals (3 to 4)
LITHUANIA PL coverage 50
LUXEMBOURG I gt99
NETHERLANDS I gt95
NORWAY - Pilots in a number of hospitals
MALTA I 3 hospitals

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 EHDI programmes in the European
area_____________________________________________
____________________
POLAND I Around 90 (Jan. 04)
PORTUGAL - Voluntary at 2 to 3 hospitals
ROMANIA PL Voluntary, at a few hospitals
SPAIN PL Supported in many Health Regions (overall 35 to 40)
SLOVENIA PL Implemented at a few hospitals
SWEDEN PI In a number of Counties
SWITZERLAND PI Implemented at many hospitals (coverage gt60)
UK - ENGLAND I Coverage 90 (May 04)

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• POLAND (2001-2003)
• 440 birthing units
• 44 audiological ctrs
• 7 IIIrd level audiological ctrs

Warsaw, Jan. 11, 2001
Warsaw, Jan. 11, 2002
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Warsaw, Jan. 11, 2004
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Dr. Zelika Antunovic, vice-President of Croatia
CROATIAN EHDI Program
Zagreb, Sett. 12, 2002
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Advocating for Universal Screening with the
Italian Minister of Health (Dec. 2003)
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LOMBARDIA

• ISTAT 1995 (Italy)
• 1,6 per 1000 severely impaired (gt70dB)
• 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

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REGIONE LOMBARDIA DIREZIONE 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
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A SUCCESSFUL UNIVERSAL NEWBORN HEARING SCREENING
PROGRAM (Milan Program)
(1998)

• 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, Ia Clinica Pediatrica
  dell'Università di Milano

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ARSI-Onlus Fondata nellanno 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

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• SUB-GROUPS
• Permanent observatory of EHDI / childhood hearing
  
• Outcomes of EHDI programs
• Genetics
• Minimum requirements / standards for screening
  and diagnostic equipment
• Pediatric audiology services

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CHILDHOODHEARING.ISIB.CNR.IT