Audiologists, by virtue of academic degree, clinical training, and license to practice, are qualified to provide guidance, development, implementation, and oversight of newborn hearing screening programs. Professional roles and activities include training screeners, monitoring program outcomes, performing screenings, advocacy, education, administration, and research. See ASHA's Scope of Practice in Audiology (ASHA, 2004).
Roles and responsibilities include
- selecting screening protocols for both the NICU and WIN;
- selecting equipment;
- training and ongoing (at least annually) monitoring of the competencies of screening personnel;
- selecting or developing family educational materials;
- monitoring key indicators (refer rates, miss rates, etc.);
- developing and implementing written policies and procedures—
- infection control procedures,
- screening techniques and process,
- documentation of screening results (in medical records, Electronic Health Record [EHR], birth certificate, and discharge summary, per hospital protocols),
- reordering of supplies and disposables,
- calibration and upgrade of equipment;
- communicating screening results to families, primary care physicians, state EHDI system, and diagnostic audiology centers when indicated;
- counseling and education;
- referring infants for audiologic and medical services.
As indicated in the Code of Ethics (ASHA, 2010), audiologists who work with in this capacity should be specifically educated and appropriately trained to do so.
Universal newborn hearing screening (UNHS) programs typically include
- parent/caregiver written education materials,
- hearing screening protocols using objective physiological test(s),
- a process for communicating screening results,
- a process for obtaining parental consent in accordance with state and federal guidelines,
- a follow-up system for infants who do not pass inpatient hearing screening or are missed by the inpatient screening program— to include repeat screening as indicated or referral for appropriate evaluation and early intervention,
- documentation and data systems to track screening and follow up,
- access to interpreters who use languages represented by the population serviced,
- written protocols,
- a quality assurance process to evaluate effectiveness of newborn screening.
(New York State Department of Health, Early Intervention Program, 2007; JCIH, 2007).
A state policy of performing screening without obtaining parental permission, or at least informing parents about screening, may violate constitutional protections of the parental role (Berge, 1992; Clayton, 1992; Fleischman, Post, & Dubler, 1994). Although many hospitals have global consents for all newborn screening procedures, screeners and personnel should be aware of hospital and state regulations regarding parental refusal.
Standard Universal Precautions
All procedures must ensure the safety of the patient and clinician and adhere to universal health precautions (e.g., prevention of bodily injury and transmission of infectious disease). Decontamination, cleaning, disinfection, and sterilization of multiple-use equipment before reuse must be carried out according to facility-specific infection control policies and procedures and according to manufacturer's instructions (Siegel, Rhinehart, Jackson, Chiarello, & Healthcare Infection Control Practices Advisory Committee, 2007).
Timing of Screening
Newborns cared for in the WIN are screened as close to hospital discharge as possible and at least prior to 1 month of age. NICU newborns are screened when they are ready for discharge and/or when they are medically stable.
Newborns who have initially passed a hearing screening are rescreened if readmitted to the hospital or if risk factors for hearing loss develop over the infant's hospital stay following the initial screening. State laws and hospital protocols may vary regarding which hospital is responsible for screening newborns transferred from one hospital to another.
Screening can be done in a nursery or quiet room with the infant resting quietly or sleeping. A sound booth is not needed. The preferred method for testing is to have the newborn resting quietly in his/her bassinette, although, if needed, the newborn can be held.
Care should be taken to screen newborns no more times than recommended in the protocol. The probability of an erroneous a "pass" outcome (i.e., of infants with hearing loss passing the screen) increases with every screen.
A newborn must pass screening in both ears during one session to be considered a "pass." If the newborn fails one ear, both ears must be rescreened. If the newborn passes the screening or the rescreening and has no risk factors for late-onset or progressive hearing loss, then the screening is complete. If the newborn passes the screen and has risk factors for late-onset or progressive hearing loss, then the newborn's hearing should be followed during early childhood (Harlor & Bower, 2009; JCIH, 2007).
Auditory brainstem response (ABR) and otoacoustic emissions (OAEs) are appropriate physiologic measures for screening the newborn population. Both are noninvasive and available in automated versions that are easily utilized by trained hospital staff.
Both ABR and OAE technologies will miss delayed-onset hearing loss, mild hearing loss, or hearing loss that is only present at isolated frequencies; and both ABR and OAE responses are affected by outer or middle ear dysfunction. That is, when a transient middle ear condition is present, both will likely result in a "failed" screen. Both OAE and ABR screening reflect physiologic processes within the auditory system and identify hearing loss most accurately from 2k to 4kHz.
Automated technologies (those that determine pass/fail or pass/refer) do not require interpretation. Automated screening equipment often has test parameters set by the manufacturer, and, therefore, different equipment may yield different screening results (New York State Department of Health, Early Intervention Program, 2007).
Even if diagnostic (i.e., non-automated) technology is used and an audiologist is interpreting the results, procedures in the nursery are limited to screening (pass/fail). Equipment used should be calibrated and maintained according to manufacturer's specifications.
The primary factors that influence the selection of screening technology include the population to be screened (i.e., WIN vs. NICU), who will be conducting the screening (i.e., audiologists vs. trained technicians), and the size of the screening population.
Auditory Brainstem Response
ABR activity is a direct measurement of the neural response to sound that is generated along the auditory system from the level of the cochlea and through the VIII nerve and pontine-level of the brainstem and that correlates with behavioral hearing measures in the mid- to high-frequency region. ABR measurements are sensitive to neural auditory disorders (i.e., auditory neuropathy). The ABR is recorded using surface electrodes that are attached to the infant's head. Click stimuli are presented through insert or muff-style earphones that are worn on both ears. ABR screening is less sensitive to middle ear debris than OAE screening, resulting in lower referral rates.
Most automated equipment presents click stimuli at 35 dB nHL at a rate of 30-37/s. If the equipment allows a choice of stimulus levels, the screening program audiologist can adjust to lower click levels.
For automated ABR or AABR, manufacturers use their own proprietary stopping rule, based on a template comparison or statistical algorithms. Most instrumentation does not allow for operators to change the stopping rule criteria.
The infant should be asleep or resting quietly for the test and positioned to reduce muscle artifact. The screener visually inspects the outer part of the ear canal to ensure the canal is clear of debris and places transducer. Both ears are screened during each session.
Otoacoustic Emissions (OAE)
OAEs—either transient-evoked OAEs (TEOAEs) or distortion product OAEs (DPOAEs)—are measured using a sensitive probe microphone inserted into the infant's ear canal. OAEs are a direct measure of outer hair cell and cochlear function in response to acoustic stimulation and yield an indirect estimate of peripheral hearing sensitivity. OAEs are not sensitive to disorders central to the outer hair cells, such as auditory neuropathy—a neural hearing loss that leaves cochlear (outer hair cell) function intact and is more prevalent in the NICU population than in the WIN population (D'Agostino & Austin, 2004). OAEs will be absent when there is outer or middle ear dysfunction or blockage.
TEOAEs use a high-level click, approximately 80 dB pSPL, and a subtraction (sometimes referred to as non-linear) paradigm to reduce stimulus artifact. DPOAEs use mid-level stimuli (f1 primary = 65 dB SPL and f2 primary = 55 dB SPL).
Many manufacturers program response criteria into the unit. At least three test frequencies—of 2000, 3000, and 4000 Hz—are evaluated during the screening. Usually, signal-to-noise ratios (SNRs) of at least 6 dB are used; however, some manufacturers will set their own SNRs. DPOAE SNRs vary depending on whether mean SNR is calculated or mean plus one or two standard deviations of noise. In addition, a minimum absolute DPOAE level of -5 dB SPL is imposed.
- TEOAEs: Typically, a minimum of 50 averages is collected before testing is terminated.
- DPOAEs: DPOAEs are often terminated based on SNR. Rather than a minimum number of averages, manufacturers choose a minimum length of averaging time.
The infant should be asleep or resting quietly for the test and positioned to reduce muscle artifact. A snug probe fit is essential for valid and reliable recordings. Ears should be screened one at a time, with the infant placed on his/her side and the ear being screened facing up. The screener visually inspects the outer part of the ear canal to ensure that the canal is patent and clear of debris. Prior to insertion of the probe, a gentle massage of the area below the tragus helps to open collapsed canal or dislodge debris that may be blocking the canal.
In OAE screenings, the stimulus level is calibrated in each ear according to the manufacturer's specifications. After stimulus level requirements have been met, OAEs are collected to meet stopping criteria. If OAEs do not appear to be present, the probe is taken out and inspected to determine if the probe is blocked with cerumen or vernix. A blocked probe should be cleaned and reinserted and the screening repeated.
Screening protocols can be broadly classified into four different categories:
- ABR only,
- OAEs only,
- OAEs with ABR rescreen only if OAE is failed,
- ABR and OAEs.
The choice of protocol for a newborn hearing screening program is based on the specific needs and requirements of the hospital and the population being screened (i.e., WIN or NICU). See a chart summarizing the protocols.
Screening with ABR Only
ABR can be used in both the NICU and WIN. The rationale for an "ABR-only" protocol is that both neural and cochlear hearing losses will be detected using one type of technology. ABR screening is recommended by the JCIH (2007) for newborns cared for in the NICU for more than 5 days because they are at greater risk for neural hearing loss.
See ABR-only protocol flow charts. Flow charts are presented for infants cared for in the NICU and WIN [PDF].
Factors To Consider
- More of the auditory system is accessed with ABR screening compared with OAEs, allowing for detection of neurologic involvement.
- ABR screening results are less susceptible to false positives due to ear canal debris than are OAE screens (Vohr et al., 2001).
- ABR screening can be less cost effective than a OAE screening, because of the higher cost of disposables (electrodes and disposable earphones) and increased personnel time (Berg, Prieve, Serpanos, & Wheaton, 2011). This cost differential may be balanced with a lower refer rate, resulting in reportedly lower or similar overall program cost (Vohr et al., 2001).
- At the time of this writing, the ABR test time is longer than OAEs, because of electrodes application (Berg, Prieve, Serpanos, & Wheaton, 2011).
- ABR will result in false positives when used with babies who have immature neurological systems that affect the ABR waveform (Turchetta et al., 2012).
Screening With OAEs Only
Otoacoustic emissions—either transient-evoked OAEs (TEOAEs) or distortion product OAEs (DPOAEs)—are recommended for use in WINs. Because OAEs are sensitive to outer ear debris and middle ear fluid that may be present at birth, most OAE screening protocols involve an outpatient rescreening of those newborns who fail the screening at hospital discharge. See an OAE-only protocol flow chart [PDF].
Factors To Consider
- OAE disposable supplies are often less expensive than those used with ABR.
- OAE test time has been reported to be shorter than ABR test time (Berg, Prieve, Serpanos, & Wheaton, 2011).
- OAEs do not detect neural hearing losses.
- OAEs have a higher inpatient refer rate as compared to ABR. Outpatient rescreening is advised for newborns who fail inpatient screening before referral to an audiologist for diagnostic testing.
- OAEs may be reduced or absent due to outer ear debris and/or middle ear fluid common in the newborn population, resulting in higher refer rates. Therefore, OAEs have a higher false positive rate than ABR.
Two-Tier Screening: OAE Followed by ABR When the OAE is Not Passed
To provide options for newborn hearing screening and to reduce overall program costs, a two-tier screening approach can be used. In this approach, OAE screening is completed on both ears, first with an ABR done only for those newborns who do not pass the OAE screen. Each ear must pass the OAE screen to be considered a "pass." If the OAE screen is failed in one or both ears, an ABR screening test is performed. If the infant passes the ABR, the baby has "passed" the hearing screening. If one or both ears do not pass the ABR, the infant is referred for outpatient diagnostic testing. See a two-tier screening protocol flow chart [PDF].
The rationale behind a two-tier approach is that OAEs have lower disposables cost and are faster to perform compared with ABR; however, OAEs have a higher fail rate than ABR. Conducting an OAE screen first reduces the number of newborns who must go on to have an ABR screen.
Factors To Consider
- The overall test time and cost of a two-tier approach may be lower than an ABR-only protocol.
- The number of referrals for diagnostic testing will be lower in a two-tier protocol than for an OAE-only protocol.
- Two types of disposables will be required and two pieces of equipment may be needed, although some manufacturers have both tests on one piece of equipment.
- Personnel must be trained on two procedures.
- Because tests differ in detecting different degrees of hearing loss, a baby may not pass the OAE screen but pass the ABR screen (Johnson et al., 2005). As a result, some children with mild hearing loss may be missed.
- A two-tier protocol may miss auditory neuropathy, because infants who pass an OAE screen will not be referred for an ABR.
Two Technology Screening: Both Auditory Brainstem and OAE
In a two-technology protocol, newborns must pass both an OAE screening and an ABR screening. Both of a newborn's ears are tested with ABR and OAEs, and each ear must pass both tests to be considered a "pass." Although pass/refer rates are available for this protocol in the NICU (Berg, Spitzer, Towers, Bartosiewicz, & Diamond, 2005) and WIN (Berg, Prieve, Serpanos, & Wheaton, 2011), no sensitivity or specificity data are available.
If a newborn fails screening for one or both technologies, he/she can be rescreened with that technology (technologies) one time only: either before hospital discharge or in an outpatient setting. If the newborn fails one or both of the second screenings in one or both ears, the newborn is referred for outpatient diagnostic testing. See a two-technology protocol flow chart [PDF].
Factors To Consider
- A two-technology protocol is more likely to detect both mild hearing loss due to the use of OAE technology and neural hearing loss due to the use of ABR.
- Two pieces of equipment or a device that includes both tests must be purchased and maintained, as well as two types of disposables.
- Personnel must be trained on both technologies.
- Additional screening time is required (Berg , Prieve, Serpanos, & Wheaton, 2011), because two procedures are done.
- Fail rates may be higher, because two screening tests must be passed (Berg, Spitzer, Towers, Bartosiewicz, & Diamond, 2005; Kirkim, Serbetcioglu, Erdag, & Ceryan, 2008).
The onset of hearing loss can occur at any time in a child's life. Developmental milestones, hearing skills, and speech and language milestones should be monitored in all children consistent with the Bright Futures/American Academy of Pediatrics (AAP) schedule. In addition, not all risk indicators for hearing loss will be identified at the time a newborn is 1 month of age, when the newborn hearing process typically ends. Children who pass newborn hearing screening but have risk indicators for hearing loss require ongoing monitoring and surveillance. If parents have concerns regarding their child's speech and language development, the child should be referred for audiologic testing and speech and language evaluation by a speech-language pathologist (SLP).
Newborn hearing screening documentation requirements are based on hospital and state mandates or protocols and can include recording of screening results into the medical record, electronic health record, birth certificate, discharge summary, or state EHDI data-system. In addition, screening results must be provided to the family and the newborn's physician. Patient records should be in full compliance with the Health Insurance Portability and Accountability Act (HIPAA, 1996).
Documentation typically includes
- child's name and date of birth,
- parent contact information, including a second contact number for each family,
- date and time of all screens,
- outcome of the screen for each ear,
- recommendations for next steps—
- hospital transfer information (if applicable),
- follow-up information (appointment date, time, place, phone number of the follow-up facility, if applicable);
- signature of personnel conducting the screen.
Collecting parental and pediatrician contact information is critical, especially for those newborns who do not pass the screen, to prevent loss to follow-up. Some states stipulate the information that needs to be reported to the appropriate governing body (e.g., state EHDI program) to effectively track newborns who are screened. See ASHA's state-by-state pages for a summary of requirements.
Parent and caregiver education regarding newborn hearing screening begins before an infant is screened. If information about the screening process is provided only after a mother is admitted to the hospital to deliver her child, she may not have the level of concentration needed to consider the information being presented. Educational materials can be included in patient education packets, as part of hospital prenatal education programs, and in public health clinic outreach programs. Materials are to be written at a 4th- to 5th-grade literacy level and available in the preferred language of the family. Important information should also be conveyed orally in the parents' preferred language.
Education materials typically include information on
- the importance of early hearing detection and intervention,
- an overview of screening process, including assurances that screening is safe and non-invasive,
- what a screening "pass" and "refer" mean,
- the importance of follow-up after screening,
- the steps involved in declining screening if desired,
- risk factors for late-onset hearing loss
- developmental milestones for typically developing children.
Communicating Screening Results
Where possible, audiologists are the professionals to communicate to the family when an infant has not passed a hearing screening. In settings in which an audiologist is not available to convey results, audiologists ensure that others (e.g., nurses, technicians, physicians) provide screening outcomes in a sensitive and considerate manner.
When communicating screening results consider
- communication is confidential and should be presented in a family-focused manner,
- information is delivered in a clear and concise manner that avoids technical jargon and in the family's preferred mode of communication,
- findings are presented in a positive manner emphasizing the importance of appropriate follow-up,
- parents are given the opportunity and encouraged to ask questions.
If an infant is referred for further testing, the audiologist provides the information in such a way that the family feels supported, yet clearly understands the importance of following up with further audiologic testing. If follow-up is needed, families should receive
- explicit recommendations on about how to secure follow-up testing, including the names and phone numbers of follow-up screening facilities;
- contact information for an audiologist to whom they can direct questions in the interim;
- local, state, and national resources to obtain information about subsequent stages of the EHDI process.
Families of newborns who pass the hearing screening should be counseled about the need for ongoing surveillance and periodic monitoring.
In 2011, 34.9% of the infants who did not pass their final newborn hearing screen did not complete follow-up and were categorized as lost to follow-up (LTF)/lost to documentation (LTD; CDC, 2013).
In general, a baby who did not receive or complete the recommended diagnostic or intervention process is designated as lost to follow-up (LTF). However, there is great variation in how this term is defined from site to site and on state and national levels.
Lost to documentation (LTD) is becoming accepted as a term distinct from LTF and includes those infants who did not pass their hearing screening and whose diagnostic or intervention status has not been reported to the EHDI program; thus, their status remains unknown to the EHDI program, despite the fact that they may have received services. There are multiple points in the EHDI process at which a child might become LTD (e.g., following screening, following diagnosis, following referral to intervention).
Combining the designations LTF and LTD under the broad heading of loss to system (LTS) has been suggested as a viable option to reduce the confusion and variability in capturing this data set within and across EHDI systems and to increase the effectiveness of follow-up strategies (Beauchaine & Hoffman, 2008).
Populations at particular risk for LTF include home births, border babies (babies who live in one state but are born in another), and babies born in one hospital and transferred to another.
The National Initiative for Children's Healthcare Quality (NICHQ) identified several change strategies to decrease loss to follow up for infants who do not pass screening, including
- scripting the communication with parents regarding the screening result;
- standardizing the process for collecting contact information, including getting a second point of contact for the family and verifying the primay care physician (PCP) or clinic responsible for follow-up at the time of the screening;
- scheduling a follow-up appointment (rescreening or diagnostic) before the family leaves the hospital and stressing its importance to the family;
- calling the family to verify the follow-up appointment and provide assistance, such as transportation vouchers if necessary;
- using fax-back forms between all parts of the care compendium (audiology, primary care physicians, etc.), including at the time of the diagnostic evaluation, to alert the PCP of the results and need for follow-up;
- obtaining consent from parents for release of information at first contact with early intervention, so that information can be shared between early intervention, PCP, and the state EDHI database.
(Russ, Hanna, DesGeorges, & Forsman, 2010)
Reducing loss to follow-up will require the involvement of numerous groups and individuals, including, but not limited to, parents and family members, hospital personnel, physicians, audiologists, SLPs, early interventionists, and state and territory departments of health.
Suggestions for improving loss to system include
- requiring hospital personnel to identify the newborn's primary care physician or clinic (Health Resources and Services Administration [HRSA], 2009),
- increasing parental education, including informing parents of what the screening entails, the urgency of early diagnosis, and what the follow-up process will be prior to screening (Alexander & van Dyck, 2006),
- improving coordination, integrated data management, and tracking systems among service providers ,
- encouraging audiologists to report diagnostic results as recommended and as required by state regulation, if appropriate,
- obtaining required consent for release of information at first contact with early intervention so that information can be entered into an EHDI database,
- maintaining consistent and stable state and federal funding for EHDI programs,
- increasing the number of hospitals that involve audiologists in the newborn hearing screening.
Program Evaluation and Quality Assurance
Various quality indicators and benchmarks can be used to evaluate quality assurance and performance relative to screening and diagnosis.
- The number of newborns who complete screening (inpatient and outpatient screen) by 1 month of age. The benchmark is 95%.
- The number of newborns referred for diagnostic audiologic evaluation. The benchmark is 4%.
- The number of newborns who failed the screening and have a comprehensive diagnostic audiologic evaluation by 3 months of age. The benchmark is 90%.
- The percentage of amplification obtained within 1 month of hearing loss confirmation for families choosing amplification for their infant. The benchmark is 95%.
Other quality assurance indicators include the
- number of follow-up appointments scheduled and recorded,
- parent/guardian satisfaction with the process,
- timeliness and accuracy of screening results documented on the birth certificate,
- capacity to analyze and report data.
In addition to program evaluations, states can also evaluate their programs as they report the statewide findings to the CDC. CDC data collection includes the number of
- live births,
- newborns screened,
- missed screens, including home births and transferred newborns,
- newborns not screened due to parental refusal,
- newborns passing the screening prior to discharge,
- newborns discharged not passing screening in one or both ears,
- infants referred for diagnostic testing,
- infants who missed the initial screen or had inconclusive results,
- infants transferred in/out of the facility,
- infants screened who were transferred in/out of the facility,
- deceased infants,
- newborns passing outpatient (re) screening,
- newborns not passing outpatient screening in one or both ears.
Laws & Regulations
Privacy regulations, including Health Insurance Portability and Accountability Act (HIPAA), Family Education Rights and Privacy Act (FERPA), Part C Privacy Regulations (IDEA), and state privacy reporting laws may adversely affect the sharing of information among service providers. However, there has been some misunderstanding regarding HIPAA's and FERPA's influence on the disclosure of information from screening programs to primary referral sources. Because disclosure is mandated by law (i.e., IDEA 2004) and the information is to be shared for public health purposes, written authorization for referrals to Part C may not be required (Houston, Behl, & White, 2008; Surprenant, 2006). Furthermore, signed consent is not needed (under FERPA) to disclose general contact information, enrollment status, and attendance of children served (Houston, Behl, & White, 2008). However, Part C has more privacy protections than FERPA and HIPAA. Signed consent is needed for Part C to share any personal information with nonparticipating providers (i.e., outside of the Part C system), but it is not needed for Part C to share information with participating providers. State laws can require more privacy protections, but not less. NICHQ has recommended that any required consent for release of information be obtained at first contact with early intervention so that information can be entered into an EHDI database (HRSA, 2009). See the Impact of Privacy Regulations.
All 50 states and the District of Columbia have EHDI laws or voluntary compliance programs that screen hearing.
Under HIPAA, hospitals and other providers who conduct infant hearing screening may share results with the state EHDI program, physicians, and audiology diagnostic centers without signed consent for the purpose of facilitating diagnosis and follow-up. Even so, some states require written consent for referrals from the hospital screening in order to facilitate referrals and expedite the process. Regardless of whether or not a consent form is required, a parent's signature can be used to document that the family has been informed of the screening results and next steps. Audiologists are responsible for understanding how privacy laws are interpreted in their specific states or programs. See frequently asked questions regarding HIPAA.
Reimbursement and Program Funding
Newborn screening funding varies from state to state, with states procuring funds from fees, Medicaid, the Title V Maternal and Child Health Block Grant program, and state general revenues (Johnson, Lloyd-Puryear, Mann, Ramos, & Therrell, 2006). The trend is to identify funding sources other than grants to ensure program continuity should grant support become unavailable. Costs associated with newborn hearing screening include those associated with the tests, such as equipment, disposables, and staff times, as well as program management costs, including data entry, data analysis, follow-up activities, and outcomes monitoring.
Through the Early Periodic Screening, Diagnosis and Treatment (EPSDT) program, a set of services and benefits are mandated for all individuals under age 21 years who are enrolled in Medicaid. Federal rules encourage partnerships between state Medicaid and Title V agencies to ensure better access to and receipt of the full range of screening, diagnostic, and treatment services. EPSDT funds are an appropriate reimbursement source for screening and diagnostic services.
There are a number of codes that can be used to describe early hearing detection testing to a payer. The procedure codes for conducting OAE or ABR hearing screenings are
92586, Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system, limited;
92558, Evoked otoacoustic emissions, screening (qualitative measurement of distortion product or transient evoked otoacoustic emissions), automated analysis.
For more information on the appropriate use of these OAE codes, see CPT coding for otoacoustic emissions.