Clinical evidence from independent research studies and leading experts in the field of audiology validates the benefits of Vivosonic technology and demonstrates the practical advantages of the Integrity™ V500 System over conventional AEP equipment.
The findings below have been translated from their English publications. To view the abstracts, articles, and presentations in English, please refer to RESEARCH ARTICLESÂ and OTHER PUBLICATIONS.
Benefits of Vivosonic Technology |
Clinical Evidence |
Integrity reduces the need for sedation |
By 66-92%.3,4 |
Integrity reduces healthcare costs |
By at least 85%.3By up to $5000 USD per patient.5,6 |
Integrity reduces wait times for ABR assessment |
From > 2 months to < 3 weeks.1,3From 5-6 months to 1 week.4 |
Integrity has significant impact on Universal Newborn Hearing Screening referrals |
Increased ability to complete diagnostic testing while a baby is an inpatient.1Reduced need for follow-up appointments. Ability to test older awake babies.4 |
Integrity is less susceptible to physiological noise compared to conventional AEP systems |
Significant advantage at 50-60 dB nHL (~15-25 dB nHL) in steady-state motor noise condition with 30-44% greater probability of obtaining a response. possible to initiate test while infant is awake and obtain wave V at 20 or 30 dB nHL.5Thresholds in (physiologic) noise at 4 kHz were significantly more reliable – fewer “No Responses” – than a competing product.7In the “Active” condition, significantly more subjects had normal Wave V thresholds with Vivosonic than a conventional machine.8 |
Integrity is less susceptible to electrical artifact |
In 4/5 cases, Integrity showed lower (better) thresholds in the NICU than a conventional AEP systems.9Effective in managing electrical and muscular artifacts for NICU ABR testing. The environment did not have to be altered to perform newborn hearing screenings.10 |
Integrity obtains estimated auditory threshold more efficiently |
Average time for ABR assessment reduced to 1 hour 20 minutes. No longer need to reserve 3 hours for an outpatient visit.1Measure AC and BC thresholds in both ears at multiple frequencies in lightly sleeping or awake infants in less than 1.5 hour, including time for other activities.11 |
Integrity accurately measures hearing thresholds and provides information that contributes to clinical decisions |
Contributed to management decision in over 90% non-sedated cases.3Clinical decisions were same or better in 95% of ears tested.9AC and TB ABR threshold responses were similar to published findings of conventional equipment that measured accuracy.11Both 40-Hz sASSR and TB-ABR accurately detected thresholds within 5-10 dB of behavioral thresholds at 4000 Hz.15 |
Integrity is effective for testing difficult-to-test populations |
Effective screening device for children who are difficult to test by behavioral methods. Significantly increased completed screening from 57% (behavioural only) to 81% (behavioral and ABR screening).12High success rates using clicks and 500 Hz TB stimuli (without sedation) with patients with cerebral palsy.13Subjects with true noise-induced hearing loss can be distinguished from those who are malingering. With other ABR systems, patients who are malingering are able to delay a response indefinitely, elevating their thresholds to levels that entitle them to receive insurance benefits.14 |
References
| 1. | Walker B (2012). Clinical Significance of Advanced ABR Technology for Newborn Hearing Screening Programs. |
| 2. | Marcoux A, Kurtz I (2013). Noise Reduction to Achieve Quality ABR Measurement. |
| 3. | Hall JW III, Sauter T (2010). Clinical Experience with New Technology For Recording Un-Sedated ABRs. |
| 4. | Sebzda JM (2010). Pediatric ABR testing without sedation? Is it possible? |
| 5. | Cone B, Norrix LW. University of Arizona. “Measuring the Advantage of Kalman-Weighted Averaging for Auditory Brainstem Response Hearing Evaluation in Infants”. American Journal of Audiology, 2015 Jun;24(2):153-68. |
| 6. | Cone B, Dean J, Norrix L, Velenovsky D (2013). Innovations in the Electrophysiologic Assessment of Infant Hearing: Cost Model. |
| 7. | Wheeler JK (2011). The Effect of Kalman Weighted Filtering and In-situ Pre-amplification on the Accuracy and Efficiency of ABR Threshold Estimation. |
| 8. | Meyer D, Moskop J, Winston A, Schupbach J (2011). ABR Results in Quiet and Active Subjects. |
| 9. | Brown DK, Hunter LL, Baroch K, Eads E (2011). Comparison of Auditory Brainstem Response Systems in the NICU Population. |
| 10. | Johnson K (2012). 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. |
| 11. | Elsayed AM, Hunter LL, Keefe DH, Feeney MP, Brown DK, Meinzen-Derr JK, Baroch K, Sullivan-Mahoney M, Francis K, Schaid LG. Cincinnati Children’s Hospital Medical Center. “Air and Bone Conduction Click and Tone-Burst Auditory Brainstem Thresholds Using Kalman Adaptive Processing in Nonsedated Normal-Hearing Infants.” Ear and Hearing, 2015 Jul-Aug;36(4):471-81. |
| 12. | Wiegers JS, Bielefeld EC, Whitelaw GM. The Ohio State University. “Utility of the Vivosonic Integrity™ auditory brainstem response system as a hearing screening device for difficult-to-test children”. International Journal of Audiology, 2015 Apr;54(4):282-8. |
| 13. | Van der Westhuizen C (2010). The Clinical Utility of the Vivosonic Integrity Auditory Brainstem Response System in Children with Cerebral Palsy. |
| 14. | Steinman A, Holdstein Y (2013). Use of the Vivosonic Integrity V500 System to Identify False Indications of Noise Induced Hearing Loss. |
| 15. | Kaf WA, Mohamed ES, Elshafiey H (2016). 40-Hz Sinusoidal Auditory Steady-State Response and Tone Burst Auditory Brainstem Response Using a Kalman Filter to Determine Thresholds Pre- and Post-Myringotomy With Grommet Tube in Children With Mild, Low-Frequency Conductive Hearing Loss. Am J Audiol, 2016 Mar;25(1):41-53. |