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Ohio Pediatric Behavioral Diagnostic Recommendations

6 months to 3 years of age

Purpose: To provide a guideline of recommended test procedures, to evaluate auditory function in infants and young children referred from newborn hearing screening, PCP screening, and/or for hearing assessment due to speech/language delay or other reason for referral. Infants and children with known hearing loss or who are referred with other concerns may also be assessed using these procedures but may require additional procedures depending on history and concerns. Goal: To address hearing screening referrals or caregiver concern by utilizing the most efficient and appropriate procedures to achieve desired outcomes. Considerations: Individual site policies, Ohio licensure law, professional code of ethics, scope of practice, infection control, safety precautions, and cultural diversity will be taken into consideration in everyday clinical practice. Outcomes • Develop an individualized test process that addresses the parent/primary caregiver’s and/or referring provider’s concerns • Determine the status of the auditory system, including level of hearing sensitivity, and identification of auditory disorder, if present • If a hearing loss is present, identify the type and degree of hearing loss/auditory disorder, and assess the impact on communication • Provide audiologic data to determine the underlying pathology of the disorder • Determine the need for further testing, audiologic management, and/or referral to other specialists

Abbreviations BO: Behavioral observation CDC: Centers for Disease Control COACH: Coalition of Ohio Audiologists and Children’s Hospitals CPA: Conditioned play audiometry OAE: Otoacoustic Emissions ODH: Ohio Department of Health PCP: Primary care provider SAT: Speech awareness threshold SRT: Speech reception threshold VRA: Visual reinforcement audiometry Selection and order of audiologic tests: Professional judgment, reason for referral, developmental ability of the patient, and patient cooperation will guide test battery and order of presentation of the

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tests. Tests should assess parent/provider concerns and should include behavioral audiometry and physiologic measures to provide sufficient cross-checks (Baldwin et al., 2010). If behavioral audiometry is inconclusive, electrophysiologic measures may be required. For detailed procedures, refer to the Pediatric Guidelines of the American Academy of Audiology: AAA Pediatric Guidelines. Guidelines for overall clinical assessment are also available at the Practice Portal of the American Speech-Language-Hearing Association for Permanent Hearing Loss: ASHA Permanent Hearing Loss CLINICAL PROCESS (Refer to Table 1 below) Equipment Verification: A daily biologic check is completed for all equipment, including each transducer, to ensure proper function. Case History: The clinician obtains a complete case history, including reason(s) for assessment, results of newborn hearing screening, including test type and referred if known, risk factors for hearing loss, birth and medical history, and any concerns for hearing. Developmental Milestones: Assessing each child’s speech, language and hearing milestones is important for guiding the assessment and follow-up recommendations. Milestones according to age may be assessed using the following tool: CDC Act Early Milestones Clinical Test Battery: A pediatric audiologic evaluation consists of a clinical test battery tailored to developmental age and risk factors. Refer to the COACH Protocol for a basic test battery of physiologic measures for patients 0 - 6 months, or when behavioral assessment is not conclusive at older ages. The method of behavioral assessment utilized is determined based upon the apparent developmental level of the patient. It may be necessary to change or modify the task during the assessment based on the patient’s ability to perform the task. In order to confirm the presence or absence of hearing loss, ear-specific and frequency-specific thresholds should be obtained. For behavioral audiometry, it may be beneficial to utilize a test assistant or parent/caregiver to maintain proper placement of transducers. Complete assessment for diagnosis of hearing status includes 4-frequency, ear specific minimal response levels (MRLs), speech thresholds and tympanometry, utilizing acoustic reflexes and OAEs for cross check validity purposes (Baldwin et al., 2010). Multiple behavioral and/or physiologic sessions may be required to obtain a complete assessment. If behavioral audiometry is unsuccessful after two attempts, referral for ABR with sedation is highly recommended to avoid delayed diagnosis of hearing loss. The urgency for obtaining complete, ear specific results should increase in the presence of parent concern, delays in speech-language or hearing skill development, and the presence of risk factors for delayed or progressive hearing loss. Follow-up Recommendations: The clinician determines whether the patient can be discharged from audiology or if further assessment or referrals are necessary. Following a diagnosis of hearing loss, and within 7 days of the diagnosis, infants and toddlers up to age 3 should be referred to Part C Early Intervention services. For guidelines on additional referrals and follow-up process, as well as intervention needs, please refer to the JCIH statement (2019).

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Reporting of Results: For infants and children under 36-months of age who either failed the newborn hearing screen or was diagnosed with hearing loss, including fluctuating conductive, the following reporting is mandated by Ohio Administrative Code 3701-40-08 Diagnostic hearing evaluations.

1. Parents/guardians/caregivers must receive the results of the hearing evaluation both verbally and in a written report format. a. Results including the type and degree of hearing loss, or diagnosis of normal hearing, for each ear, b. Risk factors for hearing loss, if any, c. Additional appointment recommendations, if any. 2. Primary care providers or medical homes must receive the results of the diagnostic evaluation within seven business days. a. Results including the type and degree of hearing loss, or diagnosis of normal hearing, for each ear, b. Risk factors for hearing loss, if any, c. Additional appointment recommendations, if any. 3. Every diagnostic evaluation, regardless of diagnosis or completion of assessment, must be reported to ODH via electronic reporting within 7 business days of the evaluation. This includes: a. Newborns and infants who did not pass the hearing screening; and b. Newborns, infants and children diagnosed with hearing loss.

Reporting Results on the hearing evaluation submission form

1. Demographics a. When entering the baby’s name, the spelling must be entered exactly as the name appears on the birth certificate. b. Uncheck the box for birth mother if the information entered in the Contact section is for someone other than the birth mother. 2. Hearing Disposition a. Every diagnostic submission must have a hearing disposition. b. The test date must reflect the actual date of the evaluation, not the date you are entering the diagnostics. c. Results that are final, meaning there is no need for additional testing, should be confirmed. d. The confirmation date and the test date must match. 3. Notes – Include pertinent information that clarifies the results or adds needed information, such as: a. Relationship of person bringing the baby to the appointment if not the mother b. Reason for the evaluation: UNHS refer, re-admit, risk factors, etc. c. Test results needing clarification; baby state while testing d. Date of the next appointment e. No shows / cancelled appointments f. Recommendations, referrals

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Table 1. Guidance Summary

Test Purpose & Rationale When to consider History: Medical and Determine parent/provider concerns Obtain on all patients audiologic and determine presence of risk factors for auditory disorders Otoscopy and physical Examine the for any Obtain on all patients examination anomalies (including malformation,

ear pit, ear tag) Determine status of auditory canal and tympanic membrane (free of debris and foreign bodies, presence of PE tube or tympanic membrane perforation, etc.) Behavioral Hearing Tests BO does not provide MRLs and is Obtain on all patients useful only as a cross-check for • Behavioral Observation Appropriate method is physiologic tests, until VRA can be (BO) (0-5 months determined by child’s obtained. BO responses should not developmental age) developmental age/abilities be recorded as thresholds of hearing sensitivity Follow up may be needed to • Visual Reinforcement obtain ear specific Assess peripheral hearing status Audiometry (VRA 6 information. months-2½ years (VRA and CPA) developmental age) Ear-specific testing is required to assess for unilateral and asymmetric hearing loss. Inserts or TDH • Conditioned Play earphones are generally well Audiometry (CPA (2½ to tolerated (Weiss et al., 2016), but if 4 to 5 years not, sound field may be used to developmental age) determine auditory access in the better ear, until ear specific data can be obtained. See Tables 2-4 for normative values. Tympanometry Assess status using single Obtain on all patients, • 1000 Hz probe tone (0-9 frequency stimulus. especially if there is a concern for middle ear months; 0-18 years for Normative data is available in the problems, unless Down Syndrome Ohio COACH Protocol and AAA contraindicated (recent population) Diagnostic Guidelines. • 226 Hz probe tone (10+ tympanoplasty, months) Use of both the 1000 Hz and 226 atresia/microtia, etc.) probe tone may be considered for use with infants between 6 and 9 months of age (JCIH, 2019)

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Test Purpose & Rationale When to consider Acoustic Reflexes Provides information related to If patient has auditory • 1000 Hz probe tone (0-9 middle ear function and the sensory, neuropathy or other months; 0-18 years for neural, and motor pathways neurologic risk factors, Down Syndrome associated with the acoustic reflex concerns and/or is non- population) arc. verbal • 226 Hz probe tone (10+ months) Wideband Tympanometry Assess middle ear status using To further assess middle wideband frequency stimulus ear disorders

Otoacoustic Emissions Assess outer hair cell function. Cross check ABR or (OAE) behavioral test results, Normative data is available in the especially with newly Ohio COACH Protocol. diagnosed SNHL, or paired with SF testing in the absence of ear specific testing

Ototoxicity assessment Speech Perception Testing Assess lowest intensity at which Suspected auditory • Speech Awareness speech can be detected or neuropathy Threshold (SAT) (age 5- recognized 24 mos. developmental Assess speech perception age) Assess speech recognition ability at a skills • Speech Reception conversational level relative to Threshold (SRT) (age 2 hearing thresholds in quiet years and older) environment • Word Recognition with developmentally- appropriate procedures and speech materials (Uhler et al., 2017)

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Note for Tables 2-4: Different normative references are needed for sound field versus earphones due to calibration differences in infants and children. All numbers rounded to nearest dB for ease of clinical use.

Table 2. Normative Data for VRA with Inserts (Parry et al., 2002)

8 to 12 mos. Frequency (Hz) Minimum response Level, dB HL 500 1000 2000 4000

Mean (SD) 16 (6) 13 (6) 7 (6) 6 (6)

Minimum 0 0 0 -5

Maximum 25 25 25 20

Table 3. Normative Data for VRA with Sound Field (Sabo et al., 2003).

Age Range (mo.) Frequency (Hz) Threshold, dB HL, Mean (SD) SAT 500 1000 2000 4000

6 to 8 14 (6) 19 (7) 19 (9) 19 (8) 23 (9)

9 to 11 13 (4) 17 (4) 15 (4) 16 (4) 19 (5)

12 to 17 12 (4) 17 (6) 14 (5) 15 (4) 19 (5)

18 to 35 11 (4) 16 (4) 15 (4) 15 (4) 17 (5)

Table 4. Normative data in relation to testing technique and age group. (Sabo et al., 2003).

5th to 95 percentile range of hearing threshold levels (dB HL).

Testing Technique Age Range (mo.) SAT(VRA) 500 1000 2000 4000 Hz or SRT (Play & Conventional)

VRA Sound field 9 to 35 mo. 5–20 10–25 10–20 10–20 10–25

CPA Inserts 25 to 35 mo. 0–15 10–20 0–20 0–15 0–20

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References

AAA Clinical Guidance Document - Assessment of Hearing in Infants and Young Children, January 23, 2020. Retrieved from https://www.audiology.org/sites/default/files/publications/resources/Clin%20Guid%20Doc_Assess_Hear _Infants_Children_1.23.20.pdf May 20, 2020.

ASHA Practice Portal on Permanent Childhood Hearing Loss. Retrieved from https://www.asha.org/PRPSpecificTopic.aspx?folderid=8589934680§ion=Assessment#Audiologic_ Test_Battery-Developmental_Age_of_6-to-36_Months May 28, 2020.

Baldwin, S.M., Gajewski, B.J., Widen, J.E. (2010). An evaluation of the cross-check principle using visual reinforcement audiometry, otoacoustic emissions, and tympanometry. J Am Acad Audiol. 21(3):187-96. doi: 10.3766/jaaa.21.3.7.

Centers for Disease Control (CDC)- Learn the Signs, Act Early Developmental Milestones. Retrieved from https://www.cdc.gov/ncbddd/actearly/milestones/index.html May 28,2020.

Joint Committee on Infant Hearing (JCIH). Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs. Retrieved from https://digitalcommons.usu.edu/cgi/viewcontent.cgi?article=1104&context=jehdi May 28, 2020.

Hounam, G.M., Hunter, L.L., Kothari, R., Malhotra, P.S., Steuerwald, W. & Wiley, S. (2018). Recommended Protocols for Diagnostic Audiological Assessment Follow-up to Newborn Hearing Screening in Ohio https://odh.ohio.gov/wps/portal/gov/odh/know-our-programs/infant-hearing- program/resources1/coach-protocols 6/4/2020.

Lewis, M.P., Bell, E.B., & Evans, A.K. (2011). A comparison of tympanometry with 226 Hz and 1000 Hz probe tones in children with Down syndrome. International Journal of Pediatric , 75, 1492-1495.

Ohio Revised Code Chapter 4753: Speech Language Pathologists and Audiologists. Retrieved from https://codes.ohio.gov/orc/4753 September 21, 2020.

Ohio Administrative Code Chapter 4753: Ohio Speech and Hearing Professionals Board. Retrieved from http://codes.ohio.gov/oac/4753 September 21, 2020.

Ohio Administrative Code 3701-40-08: Diagnostic Hearing Evaluations. Retrieved from http://codes.ohio.gov/oac/3701-40-08v1 June 4, 2020.

Parry, G., Hacking, C., Bamford, J., Day, J. (2003). Minimal Response Levels for Visual Reinforcement Audiometry in Infants. International Journal of Audiology, 42(7):413-7.

Sabo, D.L., Paradise, J.L., Kurs-Lasky, M., & Smith, C.G. (2003). Hearing levels in infants and young children in relation to testing technique, age group, and the presence or absence of middle-ear effusion. Ear and Hearing, 24, 38-47.

Uhler, K., Warner-Czyz, A., Gifford, R., PMSTB Working Group (2017). Pediatric Minimum Speech Test Battery. J Am Acad Audiol. 28(3):232-247. doi: 10.3766/jaaa.15123.

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Weiss, A., Karzon, R., Ead, B., Lieu, J. (2016). Efficacy of Earphones for 12- To 24-month-old Children During Visual Reinforcement Audiometry. International Journal of Audiology, 55(4):248-53.

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