Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.
Findings by SBU Alert
Technology and target group
More than 1 out of every 1 000 children are born with permanent hearing impairment that calls for habilitation. Early detection of hearing loss and commencement of habilitation can improve the language development of such children. Most industrialized countries have programs for detecting hearing impairment in infants. The most common approach is for children to undergo a screening test just before the age of 1. Swedish child health centers have used two distraction methods - BOEL (Gaze Orientation By Sound) and Baby-test 3000. But flaws have emerged in these screening approaches and it has been shown that only 5.4 percent of all hearing impairment in Sweden is detected before the age of 6 months. Otoacoustic Emissions (OAEs) and automated Auditory Brainstem Response (aABR), two methods that offer fresh opportunities for hearing screening of the newborn, can be performed while the baby is still at the maternity ward. A two-stage screening is often employed, i.e., a second test is performed within a few days unless the initial results give a bilateral pass. Habilitation measures - such as the fitting of hearing aids, support for the family and sign language training - can commence as soon as hearing loss is detected. The potential target group for newborn hearing screening consists of the approximately 100 000 children born in Sweden each year.
Patient benefit and risks
A number of studies and reviews of the literature indicate that screening during the neonatal period (the first month of life), using OAEs and/or aABR, results in earlier detection of congenital hearing impairment than traditional distraction tests. The only controlled (non-randomized) trial, which included 54 000 children, compared newborn with traditional screening. The number of children with bilateral hearing impairment (40 dB or greater hearing loss in the better ear) who were referred to further examination before the age of 6 months was 94 per 100 000 in the group screened during the neonatal period, as opposed to 32 per 100 000 with traditional screening. The number of false negatives was significantly lower for neonatal (4 percent) than traditional (27 percent) screening. Habilitation commenced before the age of 10 months for 59 per 100 000 of the children who underwent neonatal screening, as opposed to 25 per 100 000 of those who were screened in the traditional manner. A number of studies based on thorough observations suggest that early detection and commencement of habilitation measures improved communicative and linguistic development. There is no evidence that the actual screening of hearing has a negative impact on the child.
For screening to be ethically acceptable, any hearing impairment that is detected must be followed up by an organization that can provide rapid, effective habilitation. False positive screening results, and even early diagnosis, can upset parents during a sensitive period in the relationship with their child. Proper information, short assessment periods and the fewest possible number of false positives can minimize that risk.
Universal screening of the newborn, including diagnostic assessments, costs approximately SEK 240 per child. The adoption of such a program throughout Sweden would add approximately SEK 19 million to annual healthcare costs, ie, SEK 300 000 per additional case detected. Since hearing impairment is detected with traditional screening methods in a considerably smaller percentage of children than in Britain - the country from which the data for making the calculation was taken - the estimated cost in Sweden is approximately 30 percent less. To assess the program´s cost effectiveness, the costs of providing earlier habilitation must also be taken into consideration, as well as the financial resources that society frees up by virtue of better language development among the children affected and improved health-related quality of life for both them and their parents. No data is currently available for calculating either the lifetime costs or the health benefits of universal screening.
There is scientific evidence that newborn screening, using either OAEs or aABR, results in earlier detection of congenital hearing impairment and commencement of habilitation (Evidence grade 2)*. Limited evidence exists that earlier detection and commencement of habilitation promotes improved communication and language development in the child (Evidence grade 3)*. The evidence is satisfactory with respect to costs per case detected but insufficient when it comes to the method´s cost effectiveness.
*Grading of the level of scientific evidence for conclusions. The grading scale includes four levels;
Evidence grade 1 = strong scientific evidence,
Evidence grade 2 = moderately strong scientific evidence,
Evidence grade 3 = limited scientific evidence,
Evidence grade 4 = insufficient scientific evidence.
This summary is based on a report prepared at SBU in collaboration with Assoc. Prof. Leif Hergils, Linköping University Hospital, Linköping. It has been reviewed by Prof. Ulf Rosenhall, Karolinska University Hospital, Stockholm and Inger Uhlén, MD, Karolinska University Hospital, Stockholm.
The complete report is available only in Swedish.
SBU Alert is a service provided by SBU in collaboration with the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.
- Fortnum HM, Summerfield AQ, Marshall DH, Davis AC, Bamford JM. Prevalence of permanent childhood hearing impairment in the United Kingdom and implications for universal neonatal hearing screening: questionnaire based ascertainment study. BMJ 2001;323(7312):536-40.
- Nekahm D, Weichbold V, Welzl-Muller K. Epidemiology of permanent childhood hearing impairment in the Tyrol, 1980-94. Scand Audiol 2001;30(3):197-202.
- Moeller MP. Early intervention and language development in children who are deaf and hard of hearing. Pediatrics 2000;106(3):E43.
- Ramkalawan TW, Davis AC. The effects of hearing loss and age of intervention on some language metrics in young hearing-impaired children. Br J Audiol 1992;26(2):97-107.
- Robinshaw HM. Early intervention for hearing impairment: differences in the timing of communicative and linguistic development. Br J Audiol 1995;29(6):315-34.
- Yoshinaga-Itano C, Apuzzo ML. Identification of hearing loss after age 18 months is not early enough. Am Ann Deaf 1998;143(5):380-7.
- Yoshinaga-Itano C, Coulter D, Thomson V. Developmental outcomes of children with hearing loss born in Colorado hospitals with and without universal newborn hearing screening programs. Semin Neonatol 2001;6(6):521-9.
- Yoshinaga-Itano C, Coulter D, Thomson V. The Colorado Newborn Hearing Screening Project: effects on speech and language development for children with hearing loss. J Perinatol 2000;20(8 Pt 2):S132-7.
- Yoshinaga-Itano C, Sedey AL, Coulter DK, Mehl AL. Language of early- and later-identified children with hearing loss. Pediatrics 1998;102(5):1161-71.
- Hammes DM, Novak MA, Rotz LA, Willis M, Edmondson DM, Thomas JF. Early identification and cochlear implantation: critical factors for spoken language development. Ann Otol Rhinol Laryngol 2002;189:74-8.
- Waltzman SB, Cohen NL. Cochlear implantation in children younger than 2 years old. Am J Otol 1998;19(2):158-62.
- Anderson I, Weichbold V, D´Haese PS, Szuchnik J, Quevedo MS, Martin J et al. Cochlear implantation in children under the age of two - what do the outcomes show us? Int J Pediatr Otorhinolaryngol 2004;68(4):425-31.
- Järvholm M, Konrádsson K. Svenskt hörselbarnsregister - preliminära resultat 2001; 2002.
- Kvalitetssäkring av barnhörselvården. Att skydda skyddsnätet. Stockholm: Socialstyrelsen; 1994.
- Hur ska barnhälsovården följa barns utveckling och identifiera avvikelser? Hörsel. In: Sundelin C, editor. Barnhälsovårdens betydelse för barns hälsa: en analys av möjligheter och begränsningar i ett framtidsperspektiv. A state-of-the-art document; 1999; Sigtuna: Medicinska Forskningsrådet; 1999. p. 11-13.
- Davis A, Bamford J, Wilson I, Ramkalawan T, Forshaw M, Wright S. A critical review of the role of neonatal hearing screening in the detection of congenital hearing impairment. Health Technol Assess 1997;1(10):i-iv, 1-176.
- Järvholm M. Svenskt Hörselbarnsregister - resultat 2000; 2001.
- Magnuson M, Hergils L. Late diagnosis of congenital hearing impairment in children: the parents´ experiences and opinions. Patient Educ Couns 2000;41(3):285-94.
- Watkin PM, Beckman A, Baldwin M. The views of parents of hearing impaired children on the need for neonatal hearing screening. Br J Audiol 1995;29(5):259-62.
- Kemp DT. Stimulated acoustic emissions from within the human auditory system. J Acoust Soc Am 1978;64(5):1386-91.
- Kemp DT, Ryan S. The use of transient evoked otoacoustic emissions in neonatal hearing screening programs. Seminars in Hearing 1993;14(1):30-45.
- Mason JA, Herrmann KR. Universal infant hearing screening by automated auditory brainstem response measurement. Pediatrics 1998;101(2):221-8.
- Holst E. Hörselskadade barns väg till diagnos. 1997.
- Hergils L. How do we identify hearing impairment in early childhood? Acta Paediatr Suppl 2000;89(434):12-6.
- Kennedy CR. Neonatal screening for hearing impairment. Arch Dis Child 2000;83(5):377-83.
- Thompson DC, McPhillips H, Davis RL, Lieu TL, Homer CJ, Helfand M. Universal newborn hearing screening: summary of evidence. JAMA 2001;286(16):2000-10.
- Year 2000 position statement: principles and guidelines for early hearing detection and intervention programs. Joint Committee on Infant Hearing, American Academy of Audiology, American Academy of Pediatrics, American Speech-Language-Hearing Association, and Directors of Speech and Hearing Programs in State Health and Welfare Agencies. Pediatrics 2000;106(4):798-817.
- Controlled trial of universal neonatal screening for early identification of permanent childhood hearing impairment. Wessex Universal Neonatal Hearing Screening Trial Group. Lancet 1998;352(9145):1957-64.
- Watkin PM, Baldwin M, Dixon R, Beckman A. Maternal anxiety and attitudes to universal neonatal hearing screening. Br J Audiol 1998;32(1):27-37.
- Weichbold V, Welzl-Mueller K. Maternal concern about positive test results in universal newborn hearing screening. Pediatrics 2001;108(5):1111-6.
- Hergils L, Hergils A. Universal neonatal hearing screening--parental attitudes and concern. Br J Audiol 2000;34(6):321-7.
- Magnuson M, Hergils L. The parents´ view on hearing screening in newborns. Feelings, thoughts and opinions on otoacoustic emissions screening. Scand Audiol 1999;28(1):47-56.
- Doyle KJ, Sininger Y, Starr A. Auditory neuropathy in childhood. Laryngoscope 1998;108(9):1374-7.
- Boshuizen HC, van der Lem GJ, Kauffman-de Boer MA, van Zanten GA, Oudesluys-Murphy AM, Verkerk PH. Costs of different strategies for neonatal hearing screening: a modelling approach. Arch Dis Child Fetal Neonatal Ed 2001;85(3):F177-81.
- Dort JC, Tobolski C, Brown D. Screening strategies for neonatal hearing loss: which test is best? J Otolaryngol 2000;29(4):206-10.
- Downs MP. Universal newborn hearing screening--the Colorado story. Int J Pediatr Otorhinolaryngol 1995;32(3):257-9.
- Gorga MP, Preissler K, Simmons J, Walker L, Hoover B. Some issues relevant to establishing a universal newborn hearing screening program. J Am Acad Audiol 2001;12(2):101-12.
- Kemper AR, Downs SM. A cost-effectiveness analysis of newborn hearing screening strategies. Arch Pediatr Adolesc Med 2000;154(5):484-8.
- Keren R, Helfand M, Homer C, McPhillips H, Lieu TA. Projected cost-effectiveness of statewide universal newborn hearing screening. Pediatrics 2002;110(5):855-64.
- Kezirian EJ, White KR, Yueh B, Sullivan SD. Cost and cost-effectiveness of universal screening for hearing loss in newborns. Otolaryngol Head Neck Surg 2001;124(4):359-67.
- Lemons J, Fanaroff A, Stewart EJ, Bentkover JD, Murray G, Diefendorf A. Newborn hearing screening: costs of establishing a program. J Perinatol 2002;22(2):120-4.
- Lin HC, Shu MT, Chang KC, Bruna SM. A universal newborn hearing screening program in Taiwan. Int J Pediatr Otorhinolaryngol 2002;63(3):209-18.
- Messner AH, Price M, Kwast K, Gallagher K, Forte J. Volunteer-based universal newborn hearing screening program. Int J Pediatr Otorhinolaryngol 2001;60(2):123-30.
- Vohr BR, Oh W, Stewart EJ, Bentkover JD, Gabbard S, Lemons J et al. Comparison of costs and referral rates of 3 universal newborn hearing screening protocols. J Pediatr 2001;139(2):238-44.
- Watkin PM. Neonatal otoacoustic emission screening and the identification of deafness. Arch Dis Child Fetal Neonatal Ed 1996;74(1):F16-25.
- Weirather YP, Korth N, White KR, Downs D, Woods-Kershner N. Cost analysis of TEOAE-based universal newborn hearing screening. J Commun Disord 1997;30(6):477-92.
- Bamford J. Evaluation of the pilot implementation. In: XIV Annual Workshop on Infant Hearing Screening; 2001; Nottingham; 2001.