"In over 40 years of experience with almost every manufacturer and every AEP product ever introduced in the U.S. market, I have honestly never seen performance that compares to this product."
Thursday, March 30, 2017
Dr. Jill Smith, Director of Hearing and Speech at Children's of Alabama, will relate how Vivosonic's Integrity System resulted in reduced test times, increased productivity, and decreased sedation for ABR assessments.
by Greg Ollick, Sr., M.A.
"We brought the new Integrity Gen 2 device into environments loaded with electro- magnetic interference which is very hostile to AEP testing, and the Gen 2 system was virtually unaffected....We were able to get clear, clean ABR and ECocGh responses with the patient awake, sitting up and occasionally talking, and we obtained all of this in substantially less time than with any other system."
by Anca B.
Our journey in getting our son diagnosed was one full of anguish and uncertainties, but thanks to you, also full of hope. Jon was referred at birth after his infant hearing screening test...Tweets by Vivosonic
Greg Ollick, Sr., M.A. (2016).
Recently I have had the opportunity to work with Vivosonic on their new two-channel diagnostic Auditory Evoked Potential (AEP) system. I have been using the Integrity Gen 2 device with version 8.3 application software. We performed test trials using the default protocols for Click ABR, Tone Burst ABR, ECochG and cVEMP testing, and the results were outstanding. In over 40 years of experience with almost every manufacturer and every AEP product ever introduced in the U.S. market, I have honestly never seen performance that compares to this product. Superior digital response (signal) processing, high sampling rates and extraordinary noise immunity... [Read Product Review]
James W. Hall III, Ph.D. (2015).
Salus University, University of Pretoria. Publisher: Amazon.com.
SYNOPSIS: The eHandbook of Auditory Evoked Responses includes offers a clear and comprehensive review of auditory evoked responses from the cochlea to the cortex including test principles, protocols, and procedures for clinical application. The latest advances in clinical research and applications are covered among them the use of ECochG in ANSD and cochlear implantation, the clinical advantages of chirp stimulation in ABR and ASSR recordings, and the multiple contributions of cortical auditory evoked responses to assessment and management of pediatric and adult patients. Included in the eHandbook is a Vivosonic supplement which describes the clinical benefits of the Integrity V500 System for auditory diagnostic testing, along with the Aurix Newborn Hearing Screening System. Videos and articles are provided to demonstrate and illustrate Vivosonic's unique technologies.
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 tonebursts, ABRs in awake to sedated states, and OAEs with Integrity.
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
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
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
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
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)
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
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
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
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
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.
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
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
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
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
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
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.
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
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
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
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.
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
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