Bone-Anchored Hearing Aids Fitted According to NAL and DSL Procedures in Adults with Mixed Hearing Loss.

BACKGROUND: Bone-anchored hearing aids represent a valid alternative for patients with conductive/mixed hearing loss who cannot use hear- ing aids. To date, these devices have given good audiological results, thanks to various fitting prescription programs (i.e., National Acoustic Laboratories and Desired Sensation Level). The aim of this study is to compare 2 types of fitting algorithms (National Acoustic Laboratories and Desired Sensation Level) implemented for bone-anchored hearing devices. METHODS: We retrospectively enrolled 10 patients followed at our operative unit, suffering from bilateral symmetrical mixed hearing loss and who underwent bone-anchored hearing aid implantation. All patients experienced each prescriptive procedure, National Acoustic Laboratories and Desired Sensation Level, for 7 months (on average), and they were subjected to audiological tests and questionnaires to evaluate the best program. RESULTS: National Acoustic Laboratories and Desired Sensation Level prescriptions yielded similar results. Desired Sensation Level allowed less amplification of the low frequencies than the National Acoustic Laboratories prescription, and these differences were the only statistically sig- nificant. Desired Sensation Level allowed better disyllabic word and sentence recognition scores only in quiet and not in noisy conditions. The subjective questionnaires showed similar results. At the end of the trial sessions, more patients (60%) definitively chose the Desired Sensation Level program for their device. These patients were those with a worse hearing threshold. CONCLUSION: The 2 prescriptive programs allowed similar results although patients with a worse threshold seem to prefer the DSL program. This is the first evaluation of the 2 prescriptive programs, National Acoustic Laboratories versus Desired Sensation Level, for bone conduction devices available in the literature. Further studies are needed to confirm this initial finding.

Long-term follow-up and review of the Bone Conduction Implant.

Active transcutaneous bone conduction devices are a type of bone conduction device developed to keep the skin intact and provide direct bone conduction stimulation. The Bone Conduction Implant (BCI) is such a device and has been implanted in 16 patients. The objective of this paper is to give a broad overview of the BCI development to the final results of 13 patients at 5-year follow-up. Follow-up of these patients included audiological performance investigations, questionnaires, as well as safety evaluation and objective functionality testing of the device. Among those audiological measurements were sound field warble tone thresholds, speech recognition threshold (SRT), speech recognition score (SRS) and signal to noise ratio threshold (SNR-threshold). The accumulated implant time for all 16 patients was 113 years in February 2022. During this time, no serious adverse events have occurred. The functional improvement for the 13 patients reported in this paper was on average 29.5 dB (average over 0.5, 1, 2 and 4 kHz), while the corresponding effective gain was -12.4 dB. The SRT improvement was 24.5 dB and the SRS improvement was 38.1%, while the aided SNR-threshold was on average -6.4 dB. It was found that the BCI can give effective and safe hearing rehabilitation for patients with conductive and mild-to-moderate mixed hearing loss.

Longitudinal economic analysis of Bonebridge 601 versus percutaneous bone-anchored hearing devices over a 5-year follow-up period.

OBJECTIVES: Percutaneous bone-anchored hearing devices (pBAHDs) are the most commonly used bone conduction implants (BCI). Concerns surround the long-term complications, notably skin-related, in patients with percutaneous abutments. The active transcutaneous BCI Bonebridge system can help avoid some of these pitfalls but is often considered a second-line option due to various factors including perceived increased overall costs. DESIGN: Longitudinal economic analysis of Bonebridge BCI 601 versus pBAHD over a 5-year follow-up period. SETTING: A specialist hearing implant centre. PARTICIPANTS: Adult patients (≥16 years) with conductive hearing loss, mixed hearing loss or single-sided deafness, who received a Bonebridge or pBAHD implant between 1/7/2013 and 1/12/2018 with a minimum 12-month follow-up. MAIN OUTCOME MEASURES: We compared the mean costs per implanted patient for both implants at 1, 3 and 5 years postoperative time points. Clinical effectiveness was evaluated using objective and patient-reported outcome measures. RESULTS: The mean total cost per patient of Bonebridge was significantly higher than pBAHD at 1-year post-implantation (£8512 standard deviation [SD] £715 vs £5590 SD £1394, P < .001); however, by 5-years post-implantation this difference was no longer statistically significant (£12 453 SD £2159 vs £12 575 SD £3854, P > .05). The overall cost convergence was mainly accounted for by the increased long-term complications, revision surgery rates and higher cost of the pBAHD external processor compared to Bonebridge. CONCLUSIONS: Long-term costs of Bonebridge to healthcare providers are comparable to pBAHDs, whilst offering lower complication rates, comparable audiological benefit and patient satisfaction. Bonebridge should be considered as a first-line BCI option in appropriate cases.

ACTIVE MIDDLE EAR VIBRANT SOUNDBRIDGE SOUND IMPLANT.

The Vibrant Soundbridge represents a new approach to hearing improvement in the form of active implantable middle ear hearing device. Unlike conventional acoustic hearing aids, which increase the volume of sound that goes to the eardrum, the Vibrant Soundbridge bypasses the ear canal and eardrum by directly vibrating the small bones in the middle ear. Because of its design, no portion of the device is placed in the ear canal itself. The Vibrant Soundbridge has been approved by the FDA as a safe and effective treatment option for adults with moderate to severe sensorineural, conductive or mixed hearing losses who desire an alternative to the acoustic hearing aids, for better hearing. The paper presents a review of the active middle ear implant Vibrant Soundbridge, which has been also implanted at the Department of Otorhinolaryngology and Head and Neck Surgery, Sestre milosrdnice University Hospital Center, which is the Referral Center for Cochlear Implantation and Surgery of Hearing Impairment and Deafness of the Ministry of Health, Republic of Croatia.

Primeras experiencias con el dispositivo osteointegrado Ponto(TM) SuperPower / First experiences with the Ponto(TM) SuperPower osseointegrated device

Los dispositivos auditivos osteointegrados (DAO) Power y SuperPower presentan indicaciones para umbrales en vía ósea de 55 y 65dB, respectivamente. Realizamos un estudio observacional prospectivo de una serie de 6 casos con hipoacusia mixta en los que se realizó implantación del DAO Ponto(TM) SuperPower. Se realizaron previo a la implantación y 6 meses tras la adaptación valoraciones tonales y verbales sin y con ruido de fondo (HINTS). Todos los participantes mostraron mejoría en los resultados tonales y verbales, variando según el grado de hipoacusia contralateral. Cabe destacar los resultados verbales con ruido de fondo donde la mayoría de los pacientes obtuvieron una relación señal ruido entre 2 y 4 dB. Los resultados en los cuestionarios APHAB y GBI mostraron una reducción de la percepción del problema y una mejoría en la calidad de vida, respectivamente. Los resultados presentados reflejan la posibilidad de tratamiento de hipoacusias mixtas con el dispositivo DAO Ponto(TM) SuperPower

Osseointegrated hearing devices Power and SuperPower present indications for bone thresholds of 55 and 65 dB respectively. We conducted a prospective observational study of a series of six cases with mixed hearing loss for whom implantation of the DAO Ponto(TM) Super-Power was performed. Tonal and verbal evaluations without and with background noise (HINTS) were performed prior to implantation and six months after adaptation. All the participants showed improvement in tonal and verbal results, varying according to the degree of contralateral hearing loss. The verbal results with background noise were noteworthy, where most of the patients obtained a signal-to-noise ratio between 2 and 4 dB. The results in the APHAB and GBI questionnaires showed a reduction in the perception of the problem and an improvement in quality of life respectively. The results presented reflect the possibility of treatment of mixed hearing loss with the Ponto(TM) SuperPower device

Comparison of Satisfaction Between Patients Using Percutaneous and Transcutaneous Bone Conduction Devices.

BACKGROUND: Bone conduction devices are widely used to treat conductive and mixed hearing loss as well as single-sided deafness (SSD). A transcutaneous system was introduced recently with the clear advantage of fewer local reactions. Our goal was to evaluate and compare the satisfaction of patients with percutaneous and transcutaneous bone conduction devices. METHODS: We divided a cohort of 72 patients into groups by type of hearing loss and their relation to the use of the percutaneous or transcutaneous system. The Glasgow Benefit Inventory (GBI) questionnaire, adapted for hearing aids, was employed to assess patient satisfaction, along with an additional questionnaire covering the general usefulness of the devices. RESULTS: Overall median daily wearing time was 12 hours for the percutaneous and seven for the transcutaneous groups (p < 0.001). We found no correlation between the bone conduction level at any frequency and the GBI satisfaction score. The median total GBI score of the entire patient cohort was 30.1; median values for general, social support, and physical health subscales were 0, 37.5, and 16.7, respectively. People suffering from SSD had the lowest satisfaction rates, and these were significantly lower for the patients who used transcutaneous aids than for those with percutaneous devices (p = 0.033). Similarly, the percutaneous system brought more satisfaction to combined hearing loss patients than did the transcutaneous (p = 0.010). CONCLUSION: Both types of bone conduction devices provide a safe and efficient way to improve hearing for candidates within correct indications. Our study revealed that patients wore the transcutaneous device less than they did the percutaneous. Satisfaction was the lowest among SSD patients who used the transcutaneous device; hence it is especially important to carry out preoperative counseling for such patients.

Comparison of two different bone anchored hearing instruments: Baha-5 vs Ponto-plus.

BACKGROUND: To our knowledge, there is no study comparing Ponto Plus® (Oticon Medical AB, Askim, Sweden) and Baha® 5 (Cochlear Bone Anchored Solutions AG, Mölnlycke, Sweden) available in the literature. AIMS/OBJECTIVES: The primary aim was to compare the performance of the Baha 5 with the Ponto Plus device in terms of speech understanding in quiet and in noise. In addition, to determine statistically whether or not the difference between the abutment systems created any variation in terms of skin reaction. MATERIALS AND METHODS: Twenty bone-anchored hearing instrument users, ten in each group, were evaluated for speech understanding in quiet and several signal-to-noise ratios using the Turkish Matrix Test in a two-speaker setup. The Holger classifications were also reviewed to determine adverse skin reactions. RESULTS: It was revealed that the hearing results of both devices were similar and, when the skin reactions were compared, there was no statistically significant difference between the two-implant systems. CONCLUSIONS AND SIGNIFICANCE: Because of the similar results of the groups, it can be interpreted as the key different device features such as the size, weight, colour alternatives, and the ease of use of the devices might be important in terms of device preference.

Efficacy of Auditory Implants for Patients With Conductive and Mixed Hearing Loss Depends on Implant Center.

INTRODUCTION: Although from a technological point of view, progress is impressive, most implantable hearing devices for conductive or mixed hearing loss have a limited capacity. These devices all bypass the impaired middle ear; therefore, the desired amplification (gain) should be based on the cochlear hearing loss (component) only. The aim of the study is to review the literature with regard to accomplished gain with current implantable devices. METHOD: Thirty-one articles could be included. Aided thresholds were compared with prescribed values, based on cochlear hearing loss (bone-conduction thresholds), according to the well-validated NAL rule. RESULTS: For the majority of the studies, NAL targets were not met. Variation in accomplished gain between implant teams was unacceptably large, largely independent of the type of device that was used. NAL targets were best met at 2 kHz, with worse results at the other frequencies. CONCLUSION: Large variations in reported results were found, which primarily depended on implant center. Based on the analyses, a pragmatic fitting procedure is proposed which should minimize the differences between implant centres.

Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study.

OBJECTIVES: To compare the hearing performance of patients with conductive and mild mixed hearing loss and single-sided sensorineural deafness provided with a new transcutaneous bone conduction hearing implant (the Baha Attract System) with unaided hearing as well as aided with a sound processor on a softband. Furthermore, to evaluate safety and subjective benefit before and after implantation of the test device. PARTICIPANTS: Fifty-four adult patients in five participating centres were enrolled in this prospective study. Baseline data were collected during a pre-operative visit, and after a softband trial, all patients were implanted unilaterally. Follow-up visits were scheduled at 10 days, 4, 6, 12 weeks and 6 months. MAIN OUTCOME MEASURES: Free-field hearing thresholds pure-tone average (PTA4 in dB HL; mean threshold at 500, 1000, 2000, 4000 Hz; primary outcome measure). Individual free-field hearing thresholds, speech recognition in quiet and in noise, soft tissue status during follow-up and subjective benefit as measured with the Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and Health Utilities Index (HUI) questionnaires. RESULTS: Implantation of the Baha Attract System resulted in favourable audiological outcomes compared to unaided conditions. On the primary outcome parameter, a statistically significant improvement was observed compared to unaided hearing for the patients with conductive/mixed hearing loss (mean PTA4 difference -20.8 dB HL, SD 9.8; P < 0.0001) and for the patients with single-sided sensorineural deafness (SSD) (mean PTA4 difference -21.6 dB HL, SD 12.2; P < 0.0001). During all audiology tests, the non-test ear was blocked. Statistically significant improvements were also recorded in speech tests in quiet and noise compared to unaided hearing for the conductive/mixed hearing loss group and for speech in quiet in the SSD group. Compared to the pre-operative measurement with softband, no significant differences were recorded in the PTA4 free-field hearing threshold or the other audiological outcomes in either of the groups (P > 0.05). Soft tissue-related issues observed during follow-up included numbness, pain/discomfort at the implant site and to a lesser extent pressure-related skin complications. A declining trend was noted in the rate of these complications during follow-up. Approximately 20% of patients reported some degree of numbness and 38% (slight) pain/discomfort at final follow-up of 6 months. Good results on the subjective benefit questionnaires were observed, with statistically significant improvements on APHAB and SSQ questionnaires, and on the hearing attribute of HUI3. CONCLUSIONS: The Baha Attract System provided a significant improvement in hearing performance and subjective benefit compared to the pre-operative unaided condition (with the non-test ear blocked). Hearing performance of the Baha Attract was similar to a test situation with the same sound processor on a softband. A proportion of the patients reported numbness and pain/discomfort at the implant site during follow-up, especially during the first post-operative weeks. Based on the results of the current multicentre study, the Baha Attract can be considered as a treatment option for patients with the aforementioned hearing losses. Especially in the SSD patients, a careful selection procedure is warranted. Therefore, a pre-operative trial should be part of the decision-making process before fitting a patient with the Baha Attract System.

First experiences with the Ponto™ SuperPower osseointegrated device. / Primeras experiencias con el dispositivo osteointegrado Ponto™ SuperPower.

Osseointegrated hearing devices Power and SuperPower present indications for bone thresholds of 55 and 65 dB respectively. We conducted a prospective observational study of a series of six cases with mixed hearing loss for whom implantation of the DAO Ponto™ Super-Power was performed. Tonal and verbal evaluations without and with background noise (HINTS) were performed prior to implantation and six months after adaptation. All the participants showed improvement in tonal and verbal results, varying according to the degree of contralateral hearing loss. The verbal results with background noise were noteworthy, where most of the patients obtained a signal-to-noise ratio between 2 and 4 dB. The results in the APHAB and GBI questionnaires showed a reduction in the perception of the problem and an improvement in quality of life respectively. The results presented reflect the possibility of treatment of mixed hearing loss with the Ponto™ SuperPower device.

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System. Final order.

The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

BACKGROUND: The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders, there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. OBJECTIVE OF REVIEW: To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. TYPE OF REVIEW: Systematic review. SEARCH STRATEGY: Systematic review of the literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. EVALUATION METHOD: Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcome measures that had been extracted were then grouped into domains. RESULTS: The literature search resulted in the identification of 1434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised into 22 domains. CONCLUSIONS: The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcome measures are most suitable for inclusion in the core set.

Advanced Otosclerosis: Stapes Surgery or Cochlear Implantation?

Diagnosis and treatment of advanced otosclerosis can be controversial. In 1961, House and Sheehy defined advanced otosclerosis as hearing loss in air conduction threshold by 85 dB with nonmeasurable bone conduction. Recently, the definition of advanced otosclerosis is mostly based on the decrease of speech recognition. There are some treatment modalities: stapes surgery and hearing aids, cochlear implantation, or direct acoustic cochlear implant. The authors propose a new algorithm for treatment. If the patient is treated with cochlear implantation, the surgeon should be cautious for facial nerve stimulation after surgery because it is the most prevalent complication.

On the evaluation of a superpower sound processor for bone-anchored hearing.

OBJECTIVES: Performance of a superpower bone-anchored hearing aid (Baha), the Baha Cordelle from Cochlear Bone-Anchored Solutions (BCD1), was compared to its successor, the Baha 5 SuperPower (BCD2). DESIGN: A comparative study in which each patient served as its own control. SETTING: Tertiary clinic. PARTICIPANTS: Ten experienced BCD1 users with profound mixed hearing loss. For comparison, data from another study with 10 experienced users with a severe mixed hearing loss using a Cochlear Baha 5 power sound processor (BCD-P) were included. MAIN OUTCOME MEASURES: Speech reception thresholds in noise and APHAB and SSQ questionnaires. RESULTS: Speech reception thresholds for the digits-in-noise (DIN) test were significantly lower (P < 5%), that is more favourable, for BCD2 in the speech and noise frontal condition and in the speech frontal and noise contralateral condition than for BCD1. For the group with severe mixed loss fitted with BCD-P, the SRTs were not significantly different (P > 5%) from the BCD2 values. With the APHAB questionnaire scores were significantly lower, that is more favourable, for the ease of communication (P < 5%) and the background noise (P < 1%) domains for BCD2 than for BCD1. APHAB scores for the aversiveness of loud sounds domain were not significantly different for both devices (P > 5%). Scores for the speech and quality domains of the SSQ questionnaire were significantly higher, that is more favourable, for BCD2 than for BCD1. APHAB and SSQ scores for BCD-P were not significantly different from those for BCD2 (P > 5%). CONCLUSIONS: Data for BCD2 in profound mixed loss are similar to those for BCD-P and a severe mixed loss. Of 10 patients, 2 expressed a strong preference for BCD2 over BCD1, and 7 patients had a preference for BCD2 over BCD1. One patient preferred BCD1 because of its built-in telecoil facility.

A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device: first Nordic results.

Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. INTERVENTION: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4 was lowered by 14.7 dB. SDS was increased by 37.5% at 50 dB SPL, SRT50% in noise improved 1.4 dB. Aided thresholds improved insignificantly at frequencies above 2 kHz. 52.9% of the patients used their device every day, and 76.5% used the device at least 5 days a week. Mean IOI-HA score was 3.4, corresponding to a good benefit. In SSQ-12, "quality of hearing" scored especially high. Patients with a conductive and/or mixed hearing loss benefitted the most. This device demonstrates a significant subjective hearing benefit 8 month post surgery. In patients with conductive and/or mixed hearing losses, patient satisfaction and frequency of use were high. Objective gain measures showed less promising results especially in patients with single-sided deafness (SSD) compared to other bone conduction devices.

Indication of direct acoustical cochlea stimulation in comparison to cochlear implants.

The new implantable hearing system Codacs™ was designed to close the treatment gap between active middle ear implants and cochlear implants in cases of severe-to-profound mixed hearing loss. The Codacs™ actuator is attached to conventional stapes prosthesis during the implantation and thereby provides acoustical stimulation through a stapedotomy to the cochlea. Cochlear implants (CIs) on the other hand are an established treatment option for profoundly deaf patients including mixed hearing losses that are possible candidates for the Codacs™. In this retrospective study, we compared the clinical outcome of 25 patients with the Codacs™ (≥3 month post-activation) to 54 CI patients (two years post-activation) with comparable pre-operative bone conduction (BC) thresholds that were potential candidates for both categories of devices. The word recognition score (Freiburg monosyllables test) in quiet was significantly (p < 0.05) better in the Codacs™ than in the corresponding CI patients for average pre-operative bone conduction below 60 dB HL and equal in patients with a pre-operative BC PTA between 60 and 70 dB HL. Speech in noise intelligibility (HSM sentences test at +10 dB SNR) was significantly (p < 0.001) better in Codacs™ (80% median) than in CI patients (25% median) in all tested groups. Our results indicate for patients with sufficient cochlear reserve that speech intelligibility in noise with the Codacs™ hearing implant is significantly better than with a CI. Further, results in Codacs™ were better predictable, encouraging the extension of the indication to patients with less cochlear reserve than reported here.

Cone beam computed tomography after round window vibroplasty: do the radiological findings match the auditory outcome?

CONCLUSION: The cone beam computed tomography (CBCT) imaging technique has proved to be reliable for assessing the appropriate positioning of the floating mass transducer (FMT) in the round window (RW) niche, although some parameters do not seem to be essential for achieving a satisfactory functional outcome. OBJECTIVES: To evaluate the role that specific imaging parameters derived from CBCT of the temporal bone have for predicting the functional outcome after RW vibroplasty (RW-VP). METHODS: CBCT imaging was carried out in a homogeneous group of patients who presented with a mixed type of hearing loss after open tympanoplasty. Three arbitrary radiological parameters were taken into account: the FMT/RW membrane contact, bony contacts of the FMT margins, and the inferior FMT tissue support. The audiological assessment took into consideration the PTA4 (500-4000 Hz), the PTA2 (125-250 Hz), and the word recognition score (WRS) in quiet and in noise. RESULTS: One subject presented with all positive CBCT parameters and showed a good, but not the best auditory performance among the study group. In the majority of the subjects, with a satisfactory postoperative hearing improvement, at least two of the three radiological parameters were present. In comparison with the unaided condition, an improvement in both the PTA4 and PTA2 was found in all the subjects.

Active bone conduction system: outcomes with the Bonebridge transcutaneous device.

OBJECTIVE: To describe our experience with positioning the Bonebridge (BB) device, a semi-implantable transcutaneous bone conduction implant for patients with conductive and mixed hearing loss as well as for those suffering from single-sided deafness. METHODS: The following is a retrospective case review of 4 adults suffering from conductive or mixed hearing loss and single-sided deafness. The BB device was implanted unilaterally via 2 different approaches selected case by case: the presigmoid transmastoid and the retrosigmoid approach. An audiological evaluation in the free field was conducted to observe the functional benefit with this device. The Glasgow Health Status Inventory (GHSI) and the Glasgow Benefit Inventory (GBI) questionnaires were filled out to evaluate patients' quality of life in relationship to the intervention. RESULTS: No intra- or postoperative complications were observed. The performance in the speech test in all 4 cases reached 100% in the aided condition at 65 dB, while in the unaided condition at 65 dB, it was less than 10%. The GHSI and GBI questionnaires showed an improvement in quality of life after implantation. CONCLUSIONS: The BB device is a safe and effective solution for individuals with pathologies such as chronic otitis media, atresia auris and otosclerosis with inadequate benefit from conventional surgery or bone conduction hearing aids.

Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation.

OBJECTIVE: The aim of the investigation was to prospectively evaluate, in a multicenter setting, the clinical performance of a new magnetic bone conduction hearing implant system. METHODS: The test device was the Cochlear Baha Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). Instead of the skin-penetrating abutment of traditional bone conduction hearing implants, the test device uses an implantable and an external magnet to transmit sound from the sound processor (SP) through intact skin to the skull bone. Twenty-seven adult patients with a conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in the clinical investigation across four investigational sites. The patients were followed for 9 months after implantation. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored continuously throughout the investigation. RESULTS: Surgery and healing was uneventful. Statistically significant improvements in audibility and speech understanding in noise and quiet were recorded for the test device compared with preoperative unaided hearing. Speech recognition was similar or better than tests performed with the same SP on a softband. Good soft tissue outcomes were reported, without major pressure-related complications. At the end of the investigation, all patients continued to use and benefit from the device. CONCLUSION: The test device provides good hearing performance in patients with a conductive hearing loss or single-sided sensorineural deafness, with good wearing comfort and minimal soft tissue complications.