Hearing Aid apps: are they safe, practical and beneficial for children and teens in challenging situations?

PURPOSE: An adult version of an app giving users the control over the level of the volume, microphone directionality and noise reduction was adapted for children. The main purpose of this study was to evaluate the effect of changes made to microphone directionality and noise reduction in the myPhonak Junior (the app) on Speech intelligibility in challenging listening environments in children and teens. METHODS: The randomized, non-blinded interventional study with a single group of subjects involved two study visits with a home trial in-between. In the final study session speech assessment in noise was conducted in three different, randomly assigned conditions: default mode (Autosense Sky OS), preffered (self-adjusted) and the extreme condition. Questionnaire based assessment was conducted to assess the subjective benefit of using the app in different daily situations. RESULTS: The best scores (speech results in noise) were achieved with the preferred setting and the default Autosense Sky OS setting was significantly better than the extreme setting. The self-reported benefit through the questionnaire indicates significantly better result when adjusting the hearing aids through the app. CONCLUSION: The app is an easy-to-use way of controlling the level of noise reduction and the beam forming for children 11 years and older. It has the potential to help customizing the hearing aids beyond the default setting and helping to improve speech understanding in noise.

MRI-induced artifact by a cochlear implant with a novel magnet system: an experimental cadaver study.

PURPOSES: To primarily evaluate MRI-induced effects for Ultra 3D cochlear implantation in human cadavers in terms of artifact generation and MR image quality. METHODS: Three human cadaveric heads were submitted to imaging after unilateral and bilateral cochlear implantation. The 1.5 T MR examination protocol was chosen in accordance with our institutional protocol for the assessment of brain pathology. The maximal signal void size was measured according to each sequence and plane. Two experienced neuro-radiologists and one experienced otoneurosurgeon independently evaluated the MR image quality findings. A 4-point scale was used to describe the diagnostic usefulness of 14 brain structures. RESULTS: Shape and size of the artifacts were found to be highly related to MRI sequences and acquisition planes. MRI sequences and processing algorithms affected the ability to assess anatomical visibility. Image quality appeared either high or assessable for diagnostic purposes in 9 out of 14 of the ipsilateral structures, in at least one plane. Anatomical structures contralateral to the cochlear implant were highly visible in all conditions. Artifact intrusion clearly improved after application of metal artifact-reduction techniques. In the case of bilateral cochlear implant, a mutual interaction between the two implant magnets produced an additional artifact. CONCLUSIONS: We performed the first cadaver study aimed at systematically evaluating the MRI-induced artifacts produced by a cochlear implant with a novel four bar magnet system. Specific brain structures can be assessable for diagnostic purposes under 1.5 T MRI, with the cochlear implant magnet in place.

Evaluation of a new slim lateral wall electrode for cochlear implantation: an imaging study in human temporal bones.

PURPOSE: To evaluate the insertion characteristics and trauma of a new slim lateral wall electrode (SlimJ) in human temporal bones (TB). METHODS: Pre- and postoperative assessment was performed using cone beam computed tomography (CBCT) and image fusion in 11 human TB. The position of the array in each cochlea was analyzed and described using a vertical scaling factor, calculated by dividing the distance of the scala tympani floor to the centre of the electrode by the duct height. Insertion trauma was scaled according to the presumed localization of the basilar membrane, which was modeled from histologic sections of 20 TBs. The insertion trauma was described by the adaptation of the Eshragi trauma grading. RESULTS: A full electrode insertion, via the round window, was achieved in all TBs. Surgical handling was good, with a favorable compromise between high flexibility but sufficient stiffness to facilitate smooth insertions. The median angular insertion depth was 368° (range 330°-430°). Scala tympani placement was achieved in ten out of eleven TBs; in one TB a scala translocation was observed, occurring at approximately 180°. CONCLUSIONS: The SlimJ showed atraumatic insertion characteristics. The CBCT fusion technique provides an accurate and reliable assessment of the electrode position and allows for grading insertion trauma without histology. The SlimJ true potential for structure and hearing preservation needs to be further assessed in vivo.

A Mid-scala Cochlear Implant Electrode Design Achieves a Stable Post-surgical Position in the Cochlea of Patients Over Time-A Prospective Observational Study.

INTRODUCTION: Cochlear implant (CI) electrode design impacts the clinical performance of patients. Stability and the occurrence of electrode array migration, which is the postoperative movement of the electrode array, were investigated using a mid-scalar electrode array and postoperative image analysis. METHODS: A prospective observational study was conducted. A mid-scalar electrode was surgically placed using a mastoidectomy, followed by a posterior tympanotomy and an extended round-window or cochleostomy insertion. A few days after surgery and 3 months later Cone Beam Computed Tomography (CBCT) was performed. The two different CBCT's were fused, and the differences between the electrode positions in three dimensions were calculated (the migration). A migration greater than 0.5 mm was deemed clinically relevant. RESULTS: Fourteen subjects participated. The mid-scalar electrode migrated in one patient (7%). This did not lead to the extrusion of an electrode contact. The mean migration of every individual electrode contact in all patients was 0.36 mm (95% confidence interval 0.22-0.50 mm), which approximates to the estimated measurement error of the CBCT technique. CONCLUSION: A mid-scalar electrode array achieves a stable position in the cochlea in a small but representative group of patients. The methods applied in this work can be used for providing postoperative feedback for surgeons and for benchmarking electrode designs.

Multicenter surgical experience evaluation on the Mid-Scala electrode and insertion tools.

The HiFocus Mid-Scala electrode is intended to improve hearing for individuals with severe-to-profound hearing loss by providing extended electrical coverage of the cochlea while minimizing trauma related to insertion. The electrode is appropriate for use with a wide range of surgical techniques, including either a cochleostomy or round window insertion, and the use of either a free-hand or tool-assisted approach. The objective of this survey was to evaluate how the HiFocus Mid-Scala electrode and insertion tools was used across a population of cochlear implant recipients of differing ages, audiologic profiles, and anatomical characteristics. The intent was to understand the type and frequency of surgical techniques applicable with the electrode, and to provide guidelines for clinical practice. Two questionnaires were completed by surgeons at implant centres located in the United States, Europe, and Asia. Before any surgeries were conducted, surgeons completed a questionnaire that assessed their overall cochlear implant surgical practice and preferences. Following each HiFocus Mid-Scala electrode insertion, surgeons completed a questionnaire that summarized their experience during that surgical procedure. Questionnaires were completed by 32 surgeons from 16 centres for a total of 143 surgeries (112 adults, 31 children). Most surgeons (62 %) preferred to insert the electrode via the round window or an extended round window compared with a cochleostomy (16 %), whereas the remaining 22 % indicated that they made an insertion choice based on presenting anatomy. Sixty-nine percent preferred a free-hand approach over using insertion tools. In 32 procedures, surgeons elected to deviate from an intended round window insertion to either an extended round window or cochleostomy approach.

Insertion characteristics and placement of the Mid-Scala electrode array in human temporal bones using detailed cone beam computed tomography.

The aim of this study was to evaluate the insertion results and placement of the new Advanced Bionics HiFocus Mid-Scala (HFms) electrode array, inserted through the round window membrane, in eight fresh human temporal bones using cone beam computed tomography (CBCT). Pre- and post-insertion CBCT scans were registered to create a 3D reconstruction of the cochlea with the array inserted. With an image fusion technique both the bony edges of the cochlea and the electrode array in situ could accurately be determined, thus enabling to identify the exact position of the electrode array within the scala tympani. Vertical and horizontal scalar location was measured at four points along the cochlea base at an angular insertion depth of 90°, 180° and 270° and at electrode 16, the most basal electrode. Smooth insertion through the round window membrane was possible in all temporal bones. The imaging results showed that there were no dislocations from the scala tympani into the scala vestibule. The HFms electrode was positioned in the middle of the scala along the whole electrode array in three out of the eight bones and in 62 % of the individual locations measured along the base of the cochlea. In only one cochlea a close proximity of the electrode with the basilar membrane was observed, indicating possible contact with the basilar membrane. The results and assessments presented in this study appear to be highly accurate. Although a further validation including histopathology is needed, the image fusion technique described in this study represents currently the most accurate method for intracochlear electrode assessment obtainable with CBCT.