A Transcutaneous Active Middle Ear Implant (AMEI) in Children and Adolescents: Long-term, Multicenter Results.

OBJECTIVE: Evaluation of the long-term safety and performance of an active middle ear implant (AMEI) in the treatment of hearing loss in children and adolescents with a primary focus on improvement in speech discrimination. STUDY DESIGN: Prospective, multicentric, single-subject repeated-measures design in which each subject serves as his or her own control. SUBJECTS: Thirty-one pediatric subjects aged 5 to 17 years. INTERVENTION: Implantation of an active middle ear implant. METHODS: Improvement in word recognition scores, speech reception thresholds (SRT) in quiet and noise, in addition to air conduction, bone conduction, and sound field thresholds were evaluated in two age groups. RESULTS: Residual hearing did not change over time and speech intelligibility significantly improved and remained stable after 36 months. Children aged 5 to 9 improved in WRS from 21.92 to 95.38% and in SRT in quiet and in noise respectively from 62.45 dB SPL (sound pressure level) and +1.14 dB SNR to 42.07 dB SPL and -4.45 dB SNR. Adolescents aged 10 to 17 improved in WRS from 12.78 to 84.71% and in SRT in quiet and in noise respectively from 63.96 dB SPL and +3.32 dB SNR to 35.31 dB SPL and -4.55 dB SNR. CONCLUSIONS: The AMEI, under investigation, is a safe treatment for children and adolescents, and significantly improved audiological performance that remains stable on the long-term scale (up to 36 mo postimplantation). In general, all adult-related issues and questions regarding safety and performance can also be applied to the pediatric population, as no apparent specific issues developed.

The Vibrant Soundbridge in Children and Adolescents: Preliminary European Multicenter Results.

OBJECTIVE: Evaluation of safety and efficacy of the Vibrant Soundbridge in the treatment of hearing loss in children and adolescents with primary focus on improvement in speech discrimination. STUDY DESIGN: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. SETTING: Tertiary referral center. PATIENTS: Nineteen patients aged 5 to 17 years. INTERVENTION: Implantation of an active middle ear implant. MAIN OUTCOME MEASURE: Improvement in word recognition scores, speech reception thresholds, and signal-to-noise ratios (SNRs) were evaluated, in addition to air and bone conduction. Oldenburger Kids Satztest/Oldenburger Satztest sentences and Göttinger/Freiburger monosyllables at 65-dB hearing level were tested in two age groups. RESULTS: Significant speech discrimination improvement was seen in all patients after 6 months. In children 5 to 9 years old, mean monosyllable recognition improved from 28.9% (unaided) to 95.5% (Soundbridge-aided). Aided 50% sentence discrimination at 44.1 dB and SNR of -4.9 dB were measured. In patients 10 to 17 years old, mean word recognition improved from 18.5% to 89.0%, sentence reception threshold improved to 40.2 dB, and SNR to -3.6 dB. Comparison between age groups indicated a slight trend toward quicker adaptation by older subjects. However, after initial adjustment, a higher level of overall benefit was seen at 6 months in younger children. CONCLUSIONS: Currently, the only middle ear implant approved for pediatric patients, the Vibrant Soundbridge, provides an option in cases of congenital aural atresia or disease-induced defects, when surgical intervention and reconstruction is indicated. The 6-month results in this comparatively large study population validated conclusions found in previous trials.

Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults.

BACKGROUND: Streptococcus salivarius K12 has been shown to inhibit the growth of Streptococcus pyogenes due to bacteriocins release. Because of its ability to colonize the oral cavity, we have tested the strain K12 for its efficacy in preventing streptococcal pharyngitis and/or tonsillitis in adults. METHODS: Forty adults with a diagnosis of recurrent oral streptococcal pharyngitis were enrolled in the study. Twenty of these subjects took for 90 days a tablet containing Streptococcus salivarius K12 (Bactoblis®). The other 20 subjects served as untreated controls. A 6-month follow-up was included to evaluate any persistent protective role. RESULTS: The 20 adults who completed the 90-day course of Bactoblis® showed a reduction in their episodes of streptococcal pharyngeal infection (about 80%). The 90 days treatment was also associated with an approximately 60% reduction in the incidence of reported pharyngitis in the 6-month period following use of the product. The product was well tolerated by the subjects with no treatment-related side effects or drop-outs reported. CONCLUSION: Prophylactic administration of Streptococcus salivarius K12 to adults having a history of recurrent oral streptococcal pathology reduced the number of episodes of streptococcal pharyngeal infections and/or tonsillitis.

Speech-in-noise and subjective benefit with active middle ear implant omnidirectional and directional microphones: a within-subjects comparison.

OBJECTIVES: 1) To evaluate speech understanding in noise by comparing signal-to-noise ratios for 50% correct word understanding (SNR50) using an omnidirectional and a directional microphone audio processor (AP) in 4 different noise conditions. 2) To compare subjective speech understanding abilities, spatial hearing abilities, and qualitative hearing performance with the 2 processors. STUDY DESIGN: A prospective, single-subjects repeated-measures study design was used to compare speech understanding performance with the 2 APs acutely and after 6 weeks' acclimatization time. SETTING: Tertiary referral center. PATIENTS: Thirteen experienced unilateral German-speaking active middle ear implant users with either mixed or conductive hearing loss were enrolled. INTERVENTION: Directional audio processor. MAIN OUTCOME MEASURES: SNR50 obtained from 4 different noise conditions. RESULTS: SNR50s with the directional AP were lower (better) than with the omnidirectional AP in all noise conditions, although there were no changes in aided PTA thresholds. In acute testing, the mean SNR50 showed a significant directional advantage (DA) for the directional AP in the S0N0 condition of 1.3 dB, in S0NVSB 2.3 dB, in S0Ncont 3.1 dB, and in S0N180 4.5 dB. As expected, the largest DA was found in the S0N180 condition. No DA was expected in the S0N0 condition but was present. After 6 weeks of acclimatization time, no significant change from the acute testing was found, suggesting that patients experienced improved performance with the directional AP, even without acclimatization time. There was no significant change in subjective questionnaire outcomes. CONCLUSION: The directional AP yields immediately improved speech understanding in noise.

International consensus on Vibrant Soundbridge® implantation in children and adolescents.

OBJECTIVE: Active middle ear implants augment hearing in patients with sensorineural, conductive, and mixed hearing losses with great success. However, the application of active middle ear implants has been restricted to compromised ears in adults only. Recently, active middle ear implants have been successfully implanted in patients younger than 18 years of age with all types of hearing losses. The Vibrant Soundbridge (VSB) active middle ear implant has been implanted in more than 60 children and adolescents worldwide by the end of 2008. In October 2008, experts from the field with experience in this population met to discuss VSB implantation in patients below the age of 18. METHODS: A consensus meeting was organized including a presentation session of cases from worldwide centers and a discussion session in which implantation, precautions, and alternative means of hearing augmentation were discussed. At the end of the meeting, a consensus statement was written by the participating experts. The present consensus paper describes the outcomes and medical/surgical complications: the outcomes are favourable in terms of hearing thresholds, speech intelligibility in quiet and in noise, with a low incidence of intra- and postoperative complications. CONCLUSIONS: Taken together, the VSB offers another viable treatment for children and adolescents with compromised hearing. However, other treatment options should also be taken into consideration. The advantages and disadvantages of all possible treatment options should be weighed against each other in the light of each individual case to provide the best solution; counseling should include a.o. surgical issues and MRI compatibility.

Evaluation of auditory development in infants and toddlers who received cochlear implants under the age of 24 months with the LittlEARS) Auditory Questionnaire.

BACKGROUND AND AIMS: Newborn hearing screening and early intervention for congenital hearing loss have created a need for tools assessing the hearing development of very young children. A multidisciplinary evaluation of children's development is now becoming standard in clinical practice, though not many reliable diagnostic instruments exist. For this reason, the LittlEARS Auditory Questionnaire (LEAQ) was created to assess the auditory skills of a growing population of infants and toddlers who receive hearing instruments. The LEAQ relies on parent report, which has been shown to be a reliable way of assessing child development. Results with this tool in a group of children who received very early cochlear implantation are presented. METHODS: The LEAQ is the first module of the LittlEARS comprehensive test battery for children under the age of two who have normal hearing (NH), cochlear implants (CIs) or hearing aids (HAs). The LEAQ is a parent questionnaire comprised of 35 "yes/no" questions which can be completed by parents in less than 10 min. Sixty-three children who received unilateral CIs at a young age were assessed longitudinally and their performance was compared to that of a NH group. RESULTS: All CI children reached the maximum possible score on the LEAQ on average by 22 months of hearing age, i.e. 38 months of chronological age. In comparison, the NH group reached the maximum score by 24 months of age demonstrating that auditory skills of CI children often develop quicker than those of NH children. In the two comparison groups of children aged (a) younger and older than 12 months, and (b) between 6-9 and 21-24 months at first fitting, the early implanted children reached the highest scores faster than the later implanted children. Furthermore, three children with additional needs were tested. They showed slower growth over time but also received benefits from early implantation. CONCLUSIONS: The LEAQ is a quick and effective tool for assessing auditory skills of very young children with or without hearing loss. In our study, the auditory skills of children with CI progressed very quickly after implantation and were comparable with those of NH peers.

Coupling the Vibrant Soundbridge to cochlea round window: auditory results in patients with mixed hearing loss.

OBJECTIVE: To assess the functional results of the Vibrant Soundbridge (VBS) placed on the round window (RW) in patients with mixed hearing loss. STUDY DESIGN: Retrospective evaluation of functional hearing, with measurements performed 7 to 9 months postoperatively. SETTINGS: Two tertiary referral hospital centers. SUBJECTS: Twelve individuals with mixed severe hearing loss associated with chronic suppurative otitis media and otosclerosis. INTERVENTION: Surgical placement of the VBS mechanical effector in close contact with the RW membrane to directly drive the inner ear fluids. MAIN OUTCOME MEASUREMENT: Functional hearing gain as analyzed via pure-tone audiometry and speech audiometry with VBS off and on in quiet and in noise. RESULTS: We observed a mean gain of 37.5 dB (0.5-4 kHz) with wide individual differences. The overall gain is mainly due to the air-bone gap recovery, whereas a further 12-dB mean improvement of air-conducted threshold is evident at 2 kHz. The speech reception threshold in quiet shows a mean gain of 24 dB, whereas in noise, it requires a signal-to-noise ratio 7 to 13 dB greater than normal-hearing controls. All patients are daily users of their VBS device. CONCLUSION: A middle ear implant capable of directly driving the cochlear fluids seems to be a promising alternative for individuals with a severe to profound mixed hearing loss. However, variability in hearing recovery is great, likely reflecting variability in responsiveness of the cochlea associated with chronic pathologic findings and, possibly, variability in how the VBS effector interfaces with the RW. Modifying the shape of the VBS effector can improve the mechanical coupling to the RW to better exploit the device's amplification power.