Author Affiliations: University of Washington, Seattle (Ms Thompson and Drs McPhillips and Davis); Harvard Pilgrim Health Care, Boston, Mass (Dr Lieu), National Initiative for Children's Healthcare Quality, Boston, Mass (Dr Homer), Oregon Health & Science University, Portland VA Medical Center, Portland (Dr Helfand).
Context Each year, approximately 5000 infants are born in the United States
with moderate-to-profound, bilateral permanent hearing loss (PHL). Universal
newborn hearing screening (UNHS) has been proposed as a means to speed diagnosis
and treatment and thereby improve language outcomes in these children.
Objectives To identify strengths, weaknesses, and gaps in the evidence supporting
UNHS and to compare the additional benefits and harms of UNHS with those of
selective screening of high-risk newborns.
Data Sources We searched the MEDLINE, CINAHL, and PsychINFO databases for relevant
articles published from 1994 to August 2001, using terms for hearing disorders,
infants or newborns, screening, and relevant treatments. We contacted experts
and reviewed reference lists to identify additional articles, including those
published before 1994.
Study Selection We included controlled and observational studies of (1) the accuracy,
yield, and harms of screening using otoacoustic emissions (OAEs), auditory
brainstem response (ABR), or both in the general newborn population and (2)
the effects of screening or early identification and treatment on language
outcomes. Of an original 340 articles identified, 19 articles, including 1
controlled trial, met these inclusion criteria.
Data Extraction Data on population, test performance, outcomes, and methodological quality
were extracted by 2 authors (D.C.T., H.M.) using prespecified criteria developed
by the US Preventive Services Task Force. We queried authors when information
needed to assess study quality was missing.
Data Synthesis Good-quality studies show that from 2041 to 2794 low-risk and 86 to
208 high-risk newborns were screened to find 1 case of moderate-to-profound
PHL. The best estimate of positive predictive value was 6.7%. Six percent
to 15% of infants who are missed by the screening tests are subsequently diagnosed
with bilateral PHL. In a trial of UNHS vs clinical screening at age 8 months,
UNHS increased the proportion of infants with moderate-to-severe hearing loss
diagnosed by age 10 months (57% vs 14%) but did not reduce the rate of diagnosis
after age 18 months. No good-quality controlled study has compared UNHS with
selective screening of high-risk newborns. In fair- to poor-quality cohort
studies, intervention before age 6 months was associated with improved language
and communication skills by ages 2 to 5 years. These studies had unclear criteria
for selecting subjects, and none compared an inception cohort of low-risk
newborns identified by screening with those identified in usual care, making
it impossible to exclude selection bias as an explanation for the results.
In a mathematical model based on the literature review, we estimated that
extending screening to low-risk infants would detect 1 additional case before
age 10 months for every 1441 low-risk infants screened, and result in treatment
before 10 months of 1 additional case for every 2401 low-risk infants screened.
With UNHS, 254 newborns would be referred for audiological evaluation because
of false-positive second-stage screening test results vs 48 for selective
Conclusions Modern screening tests for hearing impairment can improve identification
of newborns with PHL, but the efficacy of UNHS to improve long-term language
outcomes remains uncertain.
Thompson DC, McPhillips H, Davis RL, Lieu TA, Homer CJ, Helfand M. Universal Newborn Hearing ScreeningSummary of Evidence. JAMA. 2001;286(16):2000–2010. doi:10.1001/jama.286.16.2000