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Valganciclovir in Infants with Hearing Loss and Clinically Inapparent Congenital Cytomegalovirus Infection: A Nonrandomized Controlled Trial

Pui Khi Chung, MD, Fleurtje A. J. Schornagel, MD, Wim Soede, PhD, Erik W. van Zwet, PhD, Aloys C. M. Kroes, Professor, MD, PhD, Anne Marie Oudesluys-Murphy, Professor, MD, PhD, and Ann C. T. M. Vossen, PhD 
J Pediatr 2024;268:113945

To assess the efficacy of valganciclovir in infants with hearing loss and clinically inapparent congenital cytomegalovirus infection (cCMV), as there is no consensus on treatment of this group.

At the follow-up age of 18–22 months, an auditory brainstem response was performed by a trained investigator during a home visit or at the study site, using a Vivosonic Integrity™ device (Vivosonic Inc., Canada).

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Predicting Behavioral Threshold at 6 and 8 kHz for Children and Adults Based on the Auditory Brainstem Response

Heather L. Porter, Christina Dubas, Manuel Vicente, Emily Buss, Danielle Bishop, Jan Kaminskia 
Am J Audiol. 2023 Jun; 32(2): 391–402

Common clinical application of ABR testing is limited to 0.25–4 kHz. As a result, information regarding high-frequency hearing sensitivity remains unknown until it is possible to obtain reliable behavioral responses to sound. For children without significant cognitive or motor delays, this may be during the pre-school and early school age years; for children and adults with disabilities, it may occur later or remain infeasible.

Delayed identification of high-frequency hearing loss is not without consequence.

In this study, the Vivosonic Integrity™ V500 and system compatible ER-2 insert earphones were used for high frequency ABR testing. This system utilizes a proprietary Kalman weighted averaging technique, SNR-Optimized Adaptive Processing (SOAP™), to facilitate testing in awake individuals.

The results of this study reduce barriers to clinical implementation of ABR testing > 4 kHz and contribute to efforts to improve hearing health care services and outcomes for patients who cannot be tested behaviorally.

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Evaluation of Hearing Impairment in Patients with Down Syndrome

Katarzyna Sienkiewicz, Krzysztof Kochanek
J Hear Sci, 2023; 13(3): 36–41
DOI: 10.17430/jhs/170894

ABRs were evoked by click stimuli from a Vivosonic Integrity V500 device (Vivosonic Inc. Toronto, Canada). Electrodes were placed on the forehead and mastoid processes. The recording bandwidth was 0.03–3 kHz. Stimuli were presented with alternating polarity through Sennheiser HDA 300 in-ear headphones. The stimulus repetition rate was 37/s, with a response analysis time of 10 ms. The number of averages ranged from 500 to 2000, depending on the number of muscle artifacts, the amplitude of the response, and the intensity of the stimulus. The test was performed using a procedure in which intensity progressed downwards in 10 dB steps from 90 dB nHL. After a recording, the peaks of waves I, III, and V were determined using a cursor, and the latency determined. A latency–intensity function was then plotted, and the hearing threshold was defined as the lowest stimulus intensity at which wave V appeared in the recording. For normal hearing, a hearing threshold criterion for ABR responses of 20 dB nHL was used.

The selection of data for analysis was guided by the principle that the ABR recordings should be of high quality, enabling reliable determination of the wave V peak and its threshold. All objective tests used in the study were non-invasive and painless. As a criterion of statistical significance, a 95% confidence level (p < 0.05) was chosen. Based on our data from 39 subjects with Down syndrome, the following conclusions can be made.

1) The ABR method is crucial for diagnosing hearing loss objectively.

2) It is possible to perform ABR testing without anesthesia.

3) DPOAE testing is often difficult to perform, due to poor cooperation on the part of the patient.



Introduction: It is estimated that the prevalence of hearing loss in children with Down syndrome (DS) ranges from 38% to 82%. However, the diagnosis of hearing loss in DS is difficult, due to an impaired ability to cooperate for subjective tests. Thus, objective tests such as impedance audiometry, otoacoustic emissions, and auditory brainstem responses (ABRs) may be more appropriate. In this study objective methods without anesthesia were used to determine the amount, type, and prevalence of hearing loss in people with DS.

Material and methods: The study included 39 subjects with DS, ranging in age from 1 year to 27 years. Hearing tests in DS subjects were performed during physiological sleep or while awake. Otoscopic examination was performed in all DS subjects. If no abnormalities were seen, tympanometry, otoacoustic emissions, and recording of ABRs were attempted.

Results: Objective hearing tests showed that the DS group had various types of hearing disorders. Based on all objective tests carried out in all ears (n = 78), the following diagnoses were made: normal hearing, 36 ears (46%); cochlear hearing loss, 27 ears (35%); conductive hearing loss, 8 ears (10%); suspected deafness, 7 ears (9%). Based on wave V thresholds, the following degrees of hearing loss were established: normal hearing, 36 ears (46%); 21–40 dB nHL, 21 ears (27%); 50–60 dB nHL, 8 ears (10%); 70–80 dB nHL, 6 ears (8%); > 80 dB nHL, 7 ears (9%).

In previous studies of DS subjects by other authors, conductive hearing loss predominated, followed by sensorineural hearing loss. In the present study, more sensorineural than conductive hearing loss was diagnosed. In most cases, the diagnosis of the type of hearing disorder was based on the ABR result, and other tests such as tympanometry and otoacoustic emissions played a supporting role. Due to the often limited cooperation of the patient, the DPOAE test was difficult to perform. [Full article]

View Journal of Hearing Science: [J Hear Sci 2023;13(3):36–41]

Evaluation of Vestibular Evoked Myogenic Potentials (VEMP) and Electrocochleography for the Diagnosis of Ménière’s Disease

Pauliana Lamouniera, Thiago Silva Almeida de Souza, Debora Aparecida Gobbo, Fayez Bahmad Jr.

ABSTRACT: Ménière’s disease (MD) is an inner ear disorder characterized by episodic vertigo, tinnitus, ear fullness, and fluctuating hearing. Its diagnosis can be especially difficult in cases where vestibular symptoms are present in isolation (vestibular MD). The definitive diagnosis is made histologically and can only be performed post-mortem, after analysis of the temporal bone. Endolymphatic hydrops is a histopathological finding of the disease and occurs more often in the cochlea and saccule, followed by the utricle and semicircular canals. Vestibular evoked myogenic potentials (VEMP) emerged as the method of assessment of vestibular function in 1994. Until then, there was no unique way of assessing saccular function and the inferior vestibular nerve. Given that the saccule is responsible for most cases of severe hydrops, VEMP appears as a new tool to assist in the diagnosis of MD. [Full Article]

The Auditory Brainstem Response: Latencies Obtained in Children While under General Anesthesia

Linda W. Norrix,* Stacey Trepanier,* Matthew Atlas,† and Darlyne Kim* (2012).

*Speech, Language and Hearing Sciences, University of Arizona, Tucson
†Tucson Medical Center, Journal of the American Academy of Audiology

Background: The auditory brainstem response (ABR) test is frequently employed to estimate hearing sensitivity and assess the integrity of the ascending auditory system. In persons who cannot participate in conventional tests of hearing, a short-acting general anesthetic is used, recordings are obtained, and the results are compared with normative data. However, several factors (e.g., anesthesia, temperature changes) can contribute to delayed absolute and interpeak latencies, making it difficult to evaluate the integrity of the person’s auditory brainstem function. Purpose: In this study, we investigated the latencies of ABR responses in children who received general anesthesia. Research Design: Between subject. Study Sample: Twelve children between the ages of 29 and 52 mo, most of whom exhibited a developmental delay but normal peripheral auditory function, comprised the anesthesia group. Twelve participants between the ages of 13 and 26 yr with normal hearing thresholds comprised the control group. Data Collection and Analysis: ABRs from a single ear from children, recorded under general anesthesia, were retrospectively analyzed and compared to those obtained from a control group with no anesthesia. ABRs were generated using 80 dB nHL rarefaction click stimuli. T-tests, corrected for alpha slippage, were employed to examine latency differences between groups. Results: There were significant delays in latencies for children evaluated under general anesthesia compared to the control group. Delays were observed for wave V and the interpeak intervals I-III, III-V, and I-V. Conclusions: Our data suggest that caution is needed in interpreting neural function from ABR data recorded while a child is under general anesthesia. [Full Article]

New Technology Helps Hearing Threshold Assessment of a Difficult-to-Test Adult

Li Qi, Ph.D, R.Aud., Senior Audiologist, Audiology Practice Lead, Vancouver General Hospital (2017).

We have successfully used the Vivosonic Integrity G1 system previously for a hearing threshold assessment in difficult-to-manage adults…Compared to G1, G2 has the following features: 1. Fast. Using the G1 system, it typically takes 1.5 to 2 hours to complete 8 frequencies assessment for both ears. We could complete the same number of tests within 1 hour using G2 system. 2. Performs well within electrically hostile noisy environments due to the new design of VivoAmp. [Full Article]

Auditory Brainstem Response and Early Diagnosis of Hearing Issues

Hunter LL1,2, Baroch KA1 (2015).

1Cincinnati Children’s Hospital Medical Center; 2University of Cincinnati. 15th EHDI Annual Meeting, 2015.

SYNOPSIS: Clinical ABR results in tough to test situations. Clinical researchers and expert practitioners share their experiences using the Integrity technology for ABR testing with both awake and sedated patients in less than ideal circumstances. The Integrity V500 System improves patient care and efficiency when working in both well-baby and NICU environments. The presentations include: case studies, experiences in high noise environments, making the transition to new technology, normative data for Integrity tone bursts, ABRs in awake to sedated states, and OAEs with Integrity.

Excerpt: Optimizing Diagnostic Auditory Brainstem Response and DPOAE

Excerpt: ABR Evaluations: Difficult Populations in Difficult Environments

Air and Bone Conduction Click and Tone-Burst Auditory Brainstem Thresholds Using Kalman Adaptive Processing in Nonsedated Normal-Hearing Infants

Elsayed AM1, Hunter LL, Keefe DH, Feeney MP, Brown DK, Meinzen-Derr JK, Baroch K, Sullivan-Mahoney M, Francis K, Schaid LG (2015).
1Communication Science Research Center, Cincinnati Children’s Hospital Medical Center. Ear and Hearing.

ABSTRACT: A study of normative thresholds and latencies for click and tone-burst auditory brainstem response (TB-ABR) for air and bone conduction in normal infants and those discharged from neonatal intensive care units, who passed newborn hearing screening and follow-up distortion product otoacoustic emission. An evoked potential system (Vivosonic Integrity) that incorporates Bluetooth electrical isolation and Kalman-weighted adaptive processing to improve signal to noise ratios was employed for this study. Results were compared with other published data. The findings report median air conduction hearing thresholds using TB-ABR ranged from 0 to 20 dB nHL, depending on stimulus frequency. Median bone conduction thresholds were 10 dB nHL across all frequencies, and median air-bone gaps were 0 dB across all frequencies. There was no significant threshold difference between left and right ears and no significant relationship between thresholds and hearing loss risk factors, ethnicity, or gender. Older age was related to decreased latency for air conduction. Compared with previous studies, mean air conduction thresholds were found at slightly lower (better) levels, while bone conduction levels were better at 2000 Hz and higher at 500 Hz. Latency values were longer at 500 Hz than previous studies using other instrumentation. Sleep state did not affect air or bone conduction thresholds. This study demonstrated slightly better wave V thresholds for air conduction than previous infant studies. The differences found in the present study, while statistically significant, were within the test step size of 10 dB. This suggests that threshold responses obtained using the Kalman weighting software were within the range of other published studies using traditional signal averaging, given step-size limitations. Thresholds were not adversely affected by variable sleep states.  [Full Article]

Measuring the advantage of Kalman-weighted averaging for ABR hearing evaluation in infants

Cone B, Norrix LW (2015).
Speech, Language, and Hearing Sciences, University of Arizona. American Journal of Audiology.

ABSTRACT: The purposes of this study were to 1) measure the effects of Kalman-weighted averaging methods on ABR threshold, latency and amplitude; 2) translate lab findings to the clinical setting; and 3) estimate cost savings when ABRs can be obtained in non-sedated infants. ABRs were recorded in 40 adults with normal hearing during induced motor noise conditions using the Kalman-weighted averaging method implemented on a commercial system, the Vivosonic Integrity™. The device was then used to test 34 infants in awake and asleep states. The advantages of the Kalman-weighted averaging method were modeled in terms of time saved for conducting an ABR evaluation. Kalman-weighted ABR threshold estimates were 6-7 dB lower than with conventional methods during induced motor noise. When used to obtain ABRs in infants who were awake, the number of sweeps required to obtain a result was significantly greater than required for a sleeping infant, but well within the range for clinical application. The use of Kalman-weighted averaging provides a measurable advantage over conventional methods and may reduce costs for the pediatric audiology practice.  [Full Article]

Utility of the Vivosonic Integrity™ auditory brainstem response system as a hearing screening device for difficult-to-test children

Wiegers JS, Bielefeld EC, Whitelaw GM (2014).
Department of Speech and Hearing Science, The Ohio State University. International Journal of Audiology.

ABSTRACT: Behavioral hearing screening is a challenge for children with developmental disorders or those who are unable or unwilling to complete a behavioral screening. This  study compared referral rates from screenings that used behavioral methods alone, with screenings that added a screen with the Vivosonic Integrity™ auditory brainstem response (ABR) device. The participant population (n = 43) consisted of children with diagnosed developmental disorders. Adding the Vivosonic Integrity to the screening protocol significantly increased the proportion of children who completed the screening, from 57% after behavioral screening to 81% after behavioral and ABR screening. The results indicate that the Vivosonic Integrity™ device could be a useful tool for hearing screening of children who are difficult to screen using behavioral procedures.  [Full Article]

Noise Reduction to Achieve Quality ABR Measurement

Marcoux A1, Kurtz I2 (2013).

1University of Ottawa; 2Vivosonic Inc. Canadian Hearing Report 2013;8(3):19-23.

ABSTRACT: Canada is a leader in the development of auditory brainstem response (ABR) technologies that enhance response detection. This article discusses the clinical challenges associated with ABR measurements and uncovers advanced technologies developed by Canadian researchers and engineers that offer noise reduction capabilities essential for achieving quality ABR measurements. These advanced technologies are transforming hearing health care around the world. [Full article]

Innovations in the Electrophysiologic Assessment of Infant Hearing

Cone B, Dean J, Norrix L, Velenovsky D (2013).

University of Arizona. AudiologyNOW! 20131. The Ruth Symposium in Audiology and Hearing Science2, Fall 2013.

ABSTRACT: New technologies for obtaining ABRs in infants were evaluated in the laboratory and clinical setting. The findings indicate that 30-45% more subjects had responses present at levels of 40-60 dB ppeSPL during steady state and intermittent motor noise when using the innovative technologies of the Vivosonic Integrity™ V500 System compared to the more conventional ABR technology of the Intelligent Hearing Systems Smart-EP. In addition, investigators observed that when evaluating a noisy infant/child using the unique adaptive Kalman filtered EEG/ABR and in-situ physiological amplifiers of the Vivosonic Integrity™, the ability to obtain a response at near threshold levels improved by up to 35% over conventional methods. Cost modeling based on the findings conservatively estimated that the use of innovative technologies could save clinics up to $300 USD per day. Furthermore, for every patient evaluated without sedation or anesthesia, the cost savings are estimated to be up to $5,000 USD per patient. Part I1 | Part II1| Cost model2 | [Full presentation2] (14 MB)

Utility of the Integrity ABR System as a Hearing Screening Device for Children who are Difficult to Test

Wiegers JS, Whitelaw GM, Bielefeld EC, Hazelbaker JM (2013).

The Ohio State University. AudiologyNOW! 2013.

ABSTRACT: The study compared the rate of ability to test from hearing screenings of preschool and school-aged children in a program that used traditional behavioral methods alone with one using the Vivosonic Integrity™ ABR device in conjunction with behavioral methods.The study demonstrated that use of the Vivosonic Integrity™ ABR device as a hearing screener for difficult-to-test children results in significantly fewer referrals for comprehensive audiologic evaluation due to an inability to test. The availability of a valid screening device for this population has the potential to save resources and provide valuable information on a child’s hearing status that may otherwise be unavailable. [Full Article]

Use of the Vivosonic Integrity V500 System to Identify False Indications of Noise Induced Hearing Loss

Steinman A1, Holdstein Y2 (2013).

1Vivosonic Inc.; 2Dr. Holdstein ENT. Clinical Brief, 2013.

ABSTRACT: The preferred method of testing for noise induced hearing loss is a behavioural test. In certain circumstances a patient may inadvertently or purposely not respond to a behavioural test and hence falsely indicate a hearing loss. Dr. Yehuda Holdstein, an expert and an ENT physician in Israel has evaluated over 10,000 cases of claimed occupational hearing loss and estimates 25% to 30% of these claims involve some degree of malingering. In cases where hearing loss is suspected to be non-organic in nature, he has successfully used the Vivosonic Integrity V500 System in a second tier battery of tests to verify the hearing loss claim. Typical methods that patients use to prevent a successful ABR involve generating excessive myogenic noise such as grinding teeth and extraneous movements. The advantages of the Vivosonic Integrity System compared to other commercially available ABR systems are the advanced myogenic and electromagnetic noise filtering technologies. Dr. Holdstein notes that patients who are malingering are able to delay a response on conventional ABR systems indefinitely, but by using the Vivosonic Integrity System he can confidently separate patients with true noise induced hearing loss from those who are malingering. [Full article]

Accuracy of TB-ABR and 40-Hz Automated & Sinusoidal ASSR Thresholds in Normal-Hearing Adult Females using Kalman-Weighted Filtering

Wilson U, Kaf W (2013).

Missouri State University. AudiologyNOW! 2013.

ABSTRACT: Behavioral testing for hearing assessment has limitations in testing newborns, special populations, and uncooperative individuals. For these individuals, evoked potentials such as Auditory Brainstem Response (ABR) and Auditory Steady State Response (ASSR) are available to objectively and reliably estimate hearing thresholds. This within-subject study compared 40-Hz ASSR automated and sinusoidal thresholds to tone-burst (TB) ABR and behavioral thresholds in awake, normal-hearing young adult females.The overall findings indicate that automated 40-Hz ASSR followed by TB-ABR are better measures for objective estimation of hearing thresholds than sinusoidal 40-Hz ASSR. [Full Article]

Clinical Significance of Advanced ABR Technology for Newborn Hearing Screening Programs

Walker B (2012).

Wesley Medical Center, Wichita, Kansas. Hearing Review Products, March 2012:16-17.

ABSTRACT: The largest birthing center in a 13-state region received a grant from the State of Kansas to purchase a Vivosonic Integrity System for non-sedated ABR testing. The coordinator of the UNHS program reports: “The Integrity system has allowed our facility to provide clear, accurate, and timely diagnostic assessments. The computer system is easy to navigate, and marking the waveforms is less time-consuming than with our previous unit. The reduction in the number of sedations saves time and money for both the family and our department. Having the ability to provide a diagnostic assessment without sedation also reduces the amount of stress that the parents and children experience. The ability to assess more of our infants prior to hospital discharge improves the referral process for intervention. If a hearing loss is discovered prior to discharge, appropriate referrals can be made with no time loss, and intervention can begin immediately.” [Full article]

Advanced ABR Technology for Screening & Diagnostics in Pediatric Audiology

Smith J (2012).

Children’s of Alabama. EHDI 2012 Annual Meeting.

ABSTRACT: This facility uses the Vivosonic Aurix™ in the NICU, NICU “step down” unit, for screening outpatient well babies who fail newborn screening, and as the first screening prior to tympanograms and diagnostic ABR. Clinical advantages of Aurix: short test time (less than 2 minutes) when babies pass; ability to obtain a pass when babies are awake, nursing, sucking on a pacifier, or fussy; very few instances of noise interference, ability to test one ear at a time; wireless technology for nursing or use in the NICU; touch screen option; insert earphone option; label printing; less expensive than competitive models. Impact of Aurix: Can screen more babies with fewer resources; fewer false positive of “active” babies; more reliable screening in the NICU; less rescheduling; reduced loss to follow up; baby and mother comfort. Vivosonic Integrity is often used in the NICU as a screener at 70 dBnHL and 30 dBnHL, NICU “step down” unit, and as 2nd stage screening following a failed screening. Clinical advantages of Integrity: Very few instances of noise interference; patient is not tethered; decreased need for sedation; portable; less expensive than other models; can test and replicate waveforms when babies/toddlers are awake, nursing, sucking on a pacifier, fussy, or mobile. Impact of Integrity: More reliable AEP in the OR; increased ability to perform outpatient diagnostic ABR; early ABR diagnostic testing; ability to test “active” babies and toddlers with rescheduling minimized; reduced loss to follow up.

Universal Newborn Hearing Screening in the NICU Population Using New Features of the Vivosonic Integrity ABR Unit: Assessing the Correlation Coefficient as a Function of the Number of Sweeps Collected

Johnson K (2012).

University of Kansas (Keener S, Ferraro J). Proceedings of Au.D. Research Day, 2012.

ABSTRACT: This research evaluates the unique features of the Vivosonic Integrity to determine if it provides distinct advantages for newborn hearing screenings in the NICU compared to conventional testing equipment. 50 NICU infants (100 ears) were screened using the Vivosonic Integrity ABR. The results indicate that the Vivosonic Integrity ABR recording unit is effective in managing electrical and muscular artifacts for NICU ABR testing, and offered advantages: 1) the testing environment did not have to be altered due to electrical artifact to perform newborn hearing screenings, and 2) accurate recordings were obtained regardless of whether or not the baby was awake, asleep, in a crib or running isolette. “We were able to get valid passing newborn hearing screenings on infants that were awake and in electrically complex locations (running isolette and being held by a parent/nurse). This would have been impossible with previous Bio-Logic NavPro ABR equipment. In the past, it wasn’t uncommon to have to sit in the waiting room waiting for the infant to fall asleep so we could perform our newborn hearing screening.” There was no significant difference in mean number of sweeps for sleep status and location, indicating that not only is the Vivosonic Integrity ABR able to achieve valid ABR results in complex testing environments, but the results for these complex environments are not significantly different than those from what was once considered the optimal testing environment (asleep in a crib). [Full article]

Effects of Subject Activity on the Auditory Brainstem Response Measured with Two Different Recording Instrument

Bruhn E (2012).

University of Kansas (Ferraro J). Proceedings of Au.D. Research Day, 2012.

ABSTRACT: This study compared ABR recordings from the same subjects using both the Vivosonic and Bio-Logic AEP units to assess which unit is more reliable under different states of subject activity. The different subject activities were relaxed and calm, and sucking on a pacifier. Ten adult left ears with normal hearing were used in this study. A 2 x 2 x 2 analyses of variance (ANOVA) was performed using the AEP units (Biologic, Vivosonic), Pacifier (Yes, No), and level (60 dB, 30 dB) as fixed factors. The dependent variables were wave V latencies, wave V correlations, and wave V apmlitudes. Findings revealed no significant difference between AEP units and the ABR variables compared in this study, with the exception that the Vivosonic Integrity produces better correlations than the Bio-Logic AEP unit due to Kalman filtering and the ability to cancel out the noise. It was also observed that testing was quicker with the Vivosonic Integrity than the Bio-Logic. Full article

Quality Improvement Initiative in Newborn Hearing Screening

Bonilla E (2011).

Ears & Hearing, Texas. Neonatal Intensive Care 2011;24(1):22-23.

ABSTRACT: Ears & Hearing is an independent service provider of newborn hearing screening (NHS) programs for 18 birthing hospitals in Texas. Their team of experienced, highly trained hearing screening technicians identified typical pain points encountered by NHS programs in the United States. In a formal study, they compared the hospitals’ current screening equipment to the Aurix Newborn Hearing Screening System, an advanced automated ABR screening product manufactured by Vivosonic. Technicians found Aurix easy to learn, and were immediately productive after a brief period of hands-on training. Overall, Aurix demonstrated better performance on the initial screen and was preferred for addressing key pain points of technicians and service providers. [Full Article]

Comparison of Auditory Brainstem Response Systems in the NICU Population

Brown DK, Hunter LL, Baroch K, Eads E (2011).

University of Cincinnati; Cincinnati Children’s Hospital Medical Center. AudiologyNOW! 2011.

ABSTRACT: Completing auditory electrophysiologic recordings in preterm infants while in a NICU environment is a challenging procedure. Completion of a QI project can assist in determining whether investment in new technology is cost-effective. This project revealed that the Vivosonic Integrity obtained lower threshold levels in this noisy environment, and was comparable to the Bio-logic NavigatorPRO in classifying type and degree of hearing status. [Full Article]

ABR Results in Quiet and Active Subjects

Meyer D, Moskop J, Winston A, Schupbach J (2011).

Rush University. AudiologyNOW! 2011.

ABSTRACT: This study investigated the clinical advantages of innovative ABR instrumentation that features in-situ amplification, weighted filtering, and wireless technology to facilitate testing of non-sedated, active patients. The Vivosonic Integrity System was compared to a conventional ABR system, the Bio-logic NavPRO, under “Quiet” and “Active” conditions with normal hearing adults. In the Quiet condition, subjects were relaxed and supine with eyes closed. In the Active condition, subjects were seated upright with eyes open, and were engaged in a gentle activity. Data revealed that the Active thresholds were markedly better with the Vivosonic machine than with the Biologic showing some statistical significance and notable clinical trends favoring the Vivosonic performance when subjects were engaged in an activity. [Full Article]

Newborn Hearing Screening: Utilization of Non-Sedated ABR to Assist with Loss to Follow-up

Abbey E1, Horsch M2 (2011).

1Kansas Department of Health and Environment; 2Via Christi Health, Kansas. EHDI 2011 Annual Meeting.

ABSTRACT: This facility is the referral hospital for infants who fail their newborn hearing screening in most of central and western Kansas, dispensing hearing aids to over 95% of all infants and children in the region. The facility was using conventional ABR equipment from three different manufacturers before acquiring the Vivosonic Integrity. In the NICU unit, electrical interference from feeding pumps, monitors, etc. was cited as the #1 problem – with much more time is spent trying to solve electrical interference issues than in actual test time – when using ABR equipment other than the Vivosonic Integrity. The audiology department was somewhat skeptical that an accurate ABR could be completed on a child that was awake, but found that Integrity worked well and now they prefer to use it over their other systems. Their other ABR equipment is now being utilized very little. The Integrity has had a tremendous impact (over 50%) on lowering the number of sedated ABRs. If sedation is needed due to issues such as intolerance to ear inserts, the Vivosonic Integrity is still considered a better option as there is much less interference from monitors and other OR equipment, and test time is easily cut in half. Conclusions: The Integrity provides accurate ABR latencies for diagnostics and easily identifiable waveforms to determine thresholds for hearing aid fittings for pediatrics, and can be used on all ages especially those who have medical conditions that contraindicate sedation.

The Effect of Kalman Weighted Filtering and In-situ Pre-amplification on the Accuracy and Efficiency of ABR Threshold Estimation

Wheeler JK (2011).

James Madison University (Ryals B). Dissertation, May 2011.

ABSTRACT: This study investigated the effects of Vivosonic’s Kalman weighted filtering techniques and in-situ pre-amplification on threshold accuracy and efficiency in an environment of high physiologic noise and compared this to a conventional Bio-logic Navigator ABR system which employed standard artifact rejection. ABR recordings were collected under quiet and noise conditions using tonal stimuli. At 4000 Hz, the Vivosonic Integrity measured significantly lower, more accurate, ABR thresholds than the conventional system regardless of activity level. The systems measured similar thresholds at 500 Hz. The Vivosonic system showed no significant differences between thresholds obtained in the presence of physiologic noise versus quiet, and was able to measure as accurately as (if not better than) a conventional system in a shorter period of time. The Vivosonic Integrity was rated as significantly more reliable by the Reviewers in noise and had significantly fewer No Responses. [Full Article]

Clinical Experience with New Technology For Recording Un-Sedated ABRs

Hall JW III1, Sauter T2 (2010).

1University of Florida; 2University of Massachusetts Medical School. AudiologyNOW! 2010.

ABSTRACT: To evaluate the feasibility of ABR measurement without sedation, ABR measurements were obtained from 103 un-sedated children using the Vivosonic Integrity System. Neurodiagnostic and/or threshold ABR measurement was also obtained from 100 adults suspected of non-organic or retrocochlear auditory dysfunction as an objective assessment. The findings provided significant evidence and support for the value of un-sedated ABR in infants and young children. The investigators concluded that the Vivosonic Integrity reduces the need for ABR assessment with sedation or anesthesia by up to 66%; reduces health care costs of a typical ABR (under anesthesia) by at least 85%; significantly reduces the wait time for an ABR assessment from more than 2 months to less than 3 weeks; and yields clinically useful ABR, enabling timely management decisions in over 90% of un-sedated children. [Full Article]

Evaluation of the Vivosonic Integrity Device for Auditory Brainstem Response Measurement

Gerhart MJ, Hall JW III, Black AL (2010).

University of Florida. AudiologyNOW! 2010.

ABSTRACT: The ABRs of normal hearing adult subjects were evaluated with the Vivosonic Integrity™ V500 System and a conventional AEP system, the GSI Audera. Correlation between the devices in a noisy (myogenic) and quiet, resting condition were investigated. The conventional system provided clinically useful data for all subjects in the quiet condition, but generated useful data for only 2 out of 10 subjects in the noisy condition. In contrast, ABR thresholds obtained with the Vivosonic Integrity device in the noisy condition were within 10 dB nHL of those obtained in the quiet condition for all subjects, providing accurate threshold estimation in the noisy condition. This demonstrates the ability of the Vivosonic Integrity system to provide accurate diagnostic analyses on active children without the need for sedation and anesthesia. [Full Article]

Pediatric ABR testing without sedation? Is it possible?

Sebzda J (2010).

Children’s Hospital of Wisconsin. EHDI 2010 Annual Meeting.

ABSTRACT: Prior to their use of the Vivosonic Integrity, CHW reported a wait period of 3-4 months for ABR testing. For children less than 6 months, the chloral hydrate protocol in use required monitoring (for 3 hours after waking up) by a physician and a nurse significantly increasing costs to families. Anesthesia used with high risk patients required an overnight stay for families. The use of the Vivosonic Integrity reduced cases of sedation by 92%, improved safety for high risk infants, reduced wait for assessments from 5-6 months to 1 week, reduced the need for follow-up appointments, improved productivity and scheduling, increased parent satisfaction, allowed testing at off-site clinics and in the NICU and OR (where the Nav Pro did not function), and had a huge impact on UNHS program with the ability to test older, awake babies. The system was reported to be very easy to learn, and the wireless technology hugely empowering. We were very impressed that we were able to successfully complete ABR testing on children while eating, drinking, nursing, playing or watching videos.  CASES: 1) A 5 month old who failed UNHS in both ears arrived awake and was tested while sucking on a pacifier. No return appointment was needed. 2) 3-year-old with Down Syndrome, with mild sensitivity loss was tested while sitting on Dad’s lap playing with toys. 3) A twin who failed screening twice was assessed with Audera diagnostic ABR and DPOAE in natural sleep at age 2 months, with findings consistent with bilateral ANSD. The assessment was repeated at 11 months with the Vivosonic Integrity, with the same results. 4) A 25 week preemie assessed at 6 month 3 weeks (adjusted age 12 weeks) referred on both ears on initial screening with Algo in the NICU. Vivosonic Integrity was used to observe the ABR waveforms and compare them to normative data, which determined hearing in both ears.

The Clinical Utility of the Vivosonic Integrity Auditory Brainstem Response System in Children with Cerebral Palsy

van der Westhuizen C (2010).

University of Pretoria (Swanepoel D, Hall JW III). Dissertation, August 2010.

ABSTRACT: Difficult-to-test populations such as cerebral palsy (CP) offers challenges for ABR due to involuntary muscular movements, as well as a high risk of airway obstruction when under Sedation or anesthesia. This study evaluated the clinical utility of the Vivosonic Integrity System when assessing children with CP without sedation. Simultaneous ABR measurements were administered using the Vivosonic Integrity and a conventional ABR system. Success rates were measured in terms of the threshold correspondence to behavioral pure tone thresholds and recording time. The findings showed the Vivosonic Integrity had high success rates of ABR recordings using click and 500 Hz TB stimuli across a wide range of subjects, higher than the Bio-Logic. To further increase the clinical usefulness of the Vivosonic Integrity with the CP population, it was suggested that a light sedative might be necessary to reduce excessive myogenic interference. [Full Article]

Advanced ABR Technology: Eliminating the need to sedate children

Kurtz I, Nishiyama R, Tedesco P (2010).

Vivosonic Inc. British Academy of Audiology Magazine, 2010; Issue 17:20-21.

ABSTRACT: Clinical evidence confirms that with recent technological advancements, ABR without sedation is a viable and practical alternative to conventional ABR practices. While ABR measurement often requires sedation and/or anaesthesia to minimise the muscular activity of infants and young children, interest in a safe and effective alternative is increasing. Recent experiences with non-sedated ABR indicate that clinical effectiveness and efficiency can be significantly improved by this approach. [Full Article]