A novel method for objective in-situ measurement of audibility in bone conduction hearing devices - a pilot study using a skin drive BCD.

OBJECTIVE: Objective measurement of audibility (verification) using bone conduction devices (BCDs) has long remained an elusive problem for BCDs. For air conduction hearing aids there are well-defined and often used objective methods, and the aim of this study is to develop an objective method for BCDs. DESIGN: In a novel setup for audibility measurements of bone-anchored hearing aid (BAHA) attached via a soft band, we used a skin microphone (SM) on the forehead measuring in-situ sound field thresholds, maximum power output (MPO) and international speech test signal (ISTS) responses. STUDY SAMPLE: Five normal-hearing persons. RESULT: Using the electrical output of SM it was possible to objectively measure the audibility of a skin drive BCD, presented as an eSPL-o-gram showing thresholds, MPO and ISTS response. Normalised eSPL-o-gram was verified against corresponding FL-o-grams (corresponding force levels from skull simulator and artificial mastoid (AM)). CONCLUSION: The proposed method with the SM can be used for objective measurements of the audibility of any BCDs based on thresholds, MPO and speech response allowing for direct comparisons of hearing and BCD output on the same graph using an eSPL-o-gram. After normalisation to hearing thresholds, the audibility can be assessed without the need for complicated calibration procedures.

The bone conduction implant BONEBRIDGE increases quality of life and social life satisfaction.

PURPOSE: Transcutaneous active bone conduction hearing aids represent an alternative approach to middle ear surgery and conventional hearing aids for patients with conductive or mixed hearing loss. The aim of this study was to determine quality of life, subjective hearing experience and patients' satisfaction after implantation of a bone conduction hearing aid. METHODS: This monocentric and retrospective study included twelve adult patients who received a bone conduction hearing aid (Bonebridge, MedEL) consisting of an extracorporeal audio processor and a bone conduction implant (BCI) between 2013 and 2017. On average 40 months after implantation, the patients were asked to answer three questionnaires regarding quality of life (AqoL-8D), self-reported auditory disability (SSQ-12-B) and user's satisfaction (APSQ) after implantation of the Bonebridge (BB). A descriptive statistical analysis of the questionnaires followed. RESULTS: 12 patients aged 26-85 years (sex: m = 7, w = 5) were recruited. The quality of life of all patients after implantation of the BB (AqoL 8D) averaged an overall utility score of 0.76 (SD ± 0.17). The mean for 'speech hearing' in the SSQ-12-B was + 2.43 (SD ± 2.03), + 1.94 (SD ± 1.48) for 'spatial hearing' and + 2.28 (SD ± 2.32) for 'qualities of hearing'. 11 out of 12 patients reported an improvement in their overall hearing. The APSQ score for the subsection 'wearing comfort' was 3.50 (SD ± 0.87), 'social life' attained a mean of 4.17 (SD ± 1.06). The 'device inconveniences' reached 4.02 (SD ± 0.71) and 'usability' of the device was measured at 4.23 (SD ± 1.06). The average wearing time of the audio processor in the cohort was 11 h per day, with 8 of 12 patients reporting the maximum length of 12 h per day. CONCLUSION: BB implantation results in a gain in the perceived quality of life (AqoL 8D). The SSQ-12-B shows an improvement in subjective hearing. According to the APSQ, it can be assumed that the BB audio processor, although in an extracorporeal position, is rated as a useful instrument with positive impact on social life. The majority stated that they had subjectively benefited from BB implantation and that there were no significant physical or sensory limitations after implantation.

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes.

PURPOSE: (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. METHODS: The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. CONCLUSIONS: The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601.

Auditory Performance and Subjective Satisfaction with the ADHEAR System.

BACKGROUND: The ADHEAR device, a new nonsurgical bone conduction hearing device, has been developed for patients with conductive hearing loss. OBJECTIVES: This study aims to assess the impact of the ADHEAR device on the audiological performance and satisfaction level in subjects with conductive hearing loss. METHODS: Twelve patients with conductive hearing loss were included. All patients received the device for 3 months. The audiological outcomes were determined using basic audiological assessments, including pure tone audiometry and sound field measurements of pure tone and speech audiometry with the contralateral ear occluded with a specific earplug. Additionally, the patients were subjectively evaluated using (1) the Speech, Spatial, and Qualities Questionnaire (SSQ), and (2) the custom-made ADHEAR questionnaire. RESULTS: Analysis of the measured audiological outcomes revealed an average improvement in pure tone thresholds (functional gain) of 23 (± 4.4) dB HL when the ADHEAR system was used compared to the unaided condition in the sound field. Moreover, speech reception thresholds improved by an average of 23 (± 15.3) dB SPL in the aided condition with plugged contralateral ear. Additionally, when using ADHEAR in the sound field, subjects' speech recognition scores improved by 32% (± 17.7) in quiet and 21% (± 15.1) in the presence of interfering noise. The average SSQ questionnaire scores improved from 3.9 at the study initiation to 6.6 after 3 months of device usage. ADHEAR custom questionnaire assessments revealed high satisfaction and acceptance of the device with no pain or skin irritation. CONCLUSION: During the study period, this new adhesive system yielded improved audiological outcomes with high patient satisfaction and acceptance and no reported skin irritation or pain.

Detailed Analysis of the Space between the Semicircular Canals for the Purpose of Direct Bone Conduction Stimulation of the Inner Ear.

INTRODUCTION: Until recently, all locations for bone conduction (BC) stimulator described in the literature were situated outside of the real otic capsule. In recent studies 2 new sites for the BC titanium implant were proposed to directly stimulate the cochlea from the closest possible distance, which was the bone forming the ampulla of the lateral semicircular canal (SC) and the bone between the superior and lateral SC. They proved to be the most efficient in terms of transmission of vibratory energy into the inner ear and could be introduced in the field of BC hearing rehabilitation. To the best of our knowledge the anatomy of the space between SC has not been studied so far. However, screwing the BC implant into the proposed new locations directly at the otic capsule and drilling the bone near the SC cast doubt on the safety of this procedure. In this study we aimed to present a detailed analysis of the anatomy of the otic capsule, especially as regards the space between the SC that seems to be safer. METHODS: Sixteen fresh frozen cadaveric temporal bones scanned with micro-computed tomography and analyzed using the multiplanar reconstruction option. The anatomy of the space between the SC was analyzed in detail for the purpose of direct BC stimulation of the inner ear. RESULTS: At least 3 mm of bony tissue is available above the bony space between the crura of the superior SC above the lateral SC, where the new location for the titanium BC implant is proposed. As regards the limitations of the length of screw the BC implant to be screwed, the smallest distance is at least 4 mm of bone thickness. CONCLUSIONS: The bone between the crura of the superior SC is the best placement to screw the BC implant directly to the otic capsule. The implant direction should be parallel to the plane of the lateral SC. This location, the direction, and the limitation of the screw length of the BC implant to a maximum of 7 mm present the lowest potential risk of damage to the inner ear.

Early Osia® 2 bone conduction hearing implant experience: Nationwide controlled-market release data and single-center outcomes.

PURPOSE: Bone conduction hearing devices are a well-established treatment option for conductive or mixed hearing losses as well as single-sided deafness. The Osia® 2 System is an active osseointegrated device where a surgically implanted titanium fixture supports a newly developed piezoelectric actuator that is placed under the skin. METHODS: Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, tertiary-level private practice Otology/Neurotology center were retrospectively reviewed. Key learnings from surgeons and audiologists are discussed. RESULTS: During the CMR period, 23 surgeons performed 44 operations on 43 recipients. The mean age of recipients was 44 years and mean surgery duration was 52 min. The most commonly used incision was postauricular but anterior to the device (78%). Five complications were observed during the CMR, none of which were device related. Twenty-one audiologists performed 33 Osia® 2 activations during the CMR. The mean age of this group was 47 years, and the mean duration of each activation appointment was 55 min. Single-center data at the authors' institution demonstrated an average additional PTA4 gain with the Osia® 2 patients of 9.6 dB compared to Baha Attract and 10.2 dB compared to Baha Connect. CONCLUSION: The Cochlear™ Osia® 2 System represents a significant advance in auditory osseointegrated implant technology. Digital piezoelectric stimulation delivers high power outputs, improves high frequency gain for optimal speech perception, and maintains safety while providing excellent patient satisfaction.

Three-Year Follow-Up with the Bone Conduction Implant.

BACKGROUND: The bone conduction implant (BCI) is an active transcutaneous bone conduction device where the transducer has direct contact to the bone, and the skin is intact. Sixteen patients have been implanted with the BCI with a planned follow-up of 5 years. This study reports on hearing, quality of life, and objective measures up to 36 months of follow-up in 10 patients. METHOD: Repeated measures were performed at fitting and after 1, 3, 6, 12, and 36 months including sound field warble tone thresholds, speech recognition thresholds in quiet, speech recognition score in noise, and speech-to-noise thresholds for 50% correct words with adaptive noise. Three quality of life questionnaires were used to capture the benefit from the intervention, appreciation from different listening situations, and the ability to interact with other people when using the BCI. The results were compared to the unaided situation and a Ponto Pro Power on a soft band. The implant functionality was measured by nasal sound pressure, and the retention force from the audio processor against the skin was measured using a specially designed audio processor and a force gauge. RESULTS: Audiometry and quality of life questionnaires using the BCI or the Ponto Pro Power on a soft band were significantly improved compared to the unaided situation and the results were statistically supported. There was generally no significant difference between the two devices. The nasal sound pressure remained stable over the study period and the force on the skin from the audio processor was 0.71 ± 0.22 N (mean ± 1 SD). CONCLUSION: The BCI improves the hearing ability for tones and speech perception in quiet and in noise for the indicated patients. The results are stable over a 3-year period, and the patients subjectively report a beneficial experience from using the BCI. The transducer performance and contact to the bone is unchanged over time, and the skin area under the audio processor remains without complications during the 3-year follow-up.

Evaluation of word recognition and word recall with bone conduction devices: do directional microphones free up cognitive resources?

Objective: To determine if directional microphones improve cognitive capacity in typically hearing adults. The study objectives are to evaluate differences in (1) speech recognition and (2) working memory through a word recall task between bilateral directional and omnidirectional microphone settings.Design: A conductive hearing loss was artificially induced while participants wore bilateral bone conduction hearing aids on softbands. For each hearing aid setting (bilateral omnidirectional and bilateral directional), seven blocks of seven sentences from the Hearing in Noise Test (HINT) were presented at a signal-to-noise ratio of +2 dB. Participants repeated each sentence aloud and after each block, wrote down as many of the last words as they could recall.Study sample: Thirty-five typical hearing adults and a subset (n = 20) achieving ≥80% recognition.Results: The directional microphone setting showed significant improvement over the omnidirectional setting for recognition and recall for both the full set of participants and the subset of participants with ≥ 80% recognition.Conclusions: This study demonstrated that features such as directional microphones can improve both speech recognition and working memory. Even in listening situations where participants can understand the majority of speech, directional microphones may offer improvements to cognitive capacity and reduce listening effort.

The effect of an active transcutaneous bone conduction device on spatial release from masking.

Objective: The aim was to quantify the effect of the experimental active transcutaneous Bone Conduction Implant (BCI) on spatial release from masking (SRM) in subjects with bilateral or unilateral conductive and mixed hearing loss.Design: Measurements were performed in a sound booth with five loudspeakers at 0°, +/-30° and +/-150° azimuth. Target speech was presented frontally, and interfering speech from either the front (co-located) or surrounding (separated) loudspeakers. SRM was calculated as the difference between the separated and the co-located speech recognition threshold (SRT).Study Sample: Twelve patients (aged 22-76 years) unilaterally implanted with the BCI were included.Results: A positive SRM, reflecting a benefit of spatially separating interferers from target speech, existed for all subjects in unaided condition, and for nine subjects (75%) in aided condition. Aided SRM was lower compared to unaided in nine of the subjects. There was no difference in SRM between patients with bilateral and unilateral hearing loss. In aided situation, SRT improved only for patients with bilateral hearing loss.Conclusions: The BCI fitted unilaterally in patients with bilateral or unilateral conductive/mixed hearing loss seems to reduce SRM. However, data indicates that SRT is improved or maintained for patients with bilateral and unilateral hearing loss, respectively.

Audiological outcome measures with the BONEBRIDGE transcutaneous bone conduction hearing implant: impact of noise, reverberation and signal processing features.

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments.Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire.Study sample: Six adults with conductive or mixed hearing loss.Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to -1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit.Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects' performance in these challenging listening environments.

The Bonebridge in Adults with Mixed and Conductive Hearing Loss: Audiological and Quality of Life Outcomes.

BACKGROUND: Considering that hearing loss has a significant impact on social functioning, everyday activity and a person's emotional state, one of the most important goals of hearing rehabilitation with bone conduction devices is improvement in a patient's quality of life. OBJECTIVES: To measure self-assessed quality of life in patients implanted with the Bonebridge, a bone conduction device. METHOD: Prospective, observational, longitudinal study with one treatment group. Twenty-one patients with mixed or conductive hearing loss were included, and each individual served as its own control. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to measure patient-reported quality of life before intervention and at 3 and 6 months after activation of the device. At the same time frames, pure-tone audiometry and speech understanding in quiet and in noise were tested. RESULTS: Hearing-specific quality of life increased significantly after intervention and remained stable up to 6 months. Both word recognition in quiet and speech reception threshold in noise were significantly better after 6 months compared to before surgery. Outcomes of aided speech understanding were independent of initial bone conduction thresholds and equally high (word recognition score >75%) across the device's indication range. CONCLUSIONS: The Bonebridge provides not only significant audiological benefit in both speech understanding in quiet and in noise, but also increases self-perceived quality of life in patients suffering from mixed and conductive hearing loss. Together with a very low rate and minor nature of adverse events, it is the state-of-the-art solution for hearing rehabilitation in patients with mixed or conductive hearing loss up to a bone conduction threshold of 45 dB HL.

Bone Conduction Amplification in Children: Stimulation via a Percutaneous Abutment versus a Transcutaneous Softband.

OBJECTIVES: Research suggests that the speech perception of children using bone conduction amplification improves if the device is coupled to an implanted abutment rather than to a softband. The purpose of the present study was to determine if the benefit of direct stimulation via an abutment is limited to small improvements in speech perception or if similar or greater benefits occur for other auditory tasks important for learning and communication. DESIGN: Fourteen children (7 to 15 years of age) with bilateral conductive and three children with unilateral conductive or sensorineural hearing loss were enrolled. Each child completed four tasks while using a bone conduction device coupled to an implanted abutment and with the device coupled to a softband. The two devices were worn at the same time and activated one at a time for testing. The children completed four tasks under each coupling condition: (a) a traditional word recognition task, (b) an auditory lexical decision task in which the children repeated aloud, and indicated the category of, real and nonsense words, (c) a nonsense-word detection task which required the children to identify nonsense words within short sentences, and (d) a rapid word learning task in which the children learned to associate nonsense words with novel images. RESULTS: Regression analyses revealed that age, duration of device use, in-situ hearing thresholds, or device output did not account for a significant portion of the variability in performance for any of the four tasks. Repeated-measures analysis of variance revealed significant increases in word recognition with the abutment as well as significantly better performance for the lexical decision and word learning tasks. The data indicated that the children with the poorest performance with the softband tended to benefit most with the abutment. Also, the younger children showed improved performance for more tasks with the abutment than the older children. No difference between coupling conditions was observed for nonsense-word detection. CONCLUSIONS: The improved recognition of familiar words, categorization and repetition of nonsense words, and speed of word learning with the abutment suggests that direct stimulation provides a higher-quality signal than indirect stimulation through a softband. Because these processes are important for vocabulary acquisition and language development, children may experience long-term benefits of direct stimulation for academic, social, and vocational purposes in addition to immediate improvement in communication.

Benefit of Higher Maximum Force Output on Listening Effort in Bone-Anchored Hearing System Users: A Pupillometry Study.

OBJECTIVES: The aim of this study was to compare listening effort, as estimated via pupillary response, during a speech-in-noise test in bone-anchored hearing system (BAHS) users wearing three different sound processors. The three processors, Ponto Pro (PP), Ponto 3 (P3), and Ponto 3 SuperPower (P3SP), differ in terms of maximum force output (MFO) and MFO algorithm. The hypothesis was that listeners would allocate lower listening effort with the P3SP than with the PP, as a consequence of a higher MFO and, hence, fewer saturation artifacts in the signal. DESIGN: Pupil dilations were recorded in 21 BAHS users with a conductive or mixed hearing loss, during a speech-in-noise test performed at positive signal-to-noise ratios (SNRs), where the speech and noise levels were individually adjusted to lead to 95% correct intelligibility with the PP. The listeners had to listen to a sentence in noise, retain it for 3 seconds and then repeat it, while an eye-tracking camera recorded their pupil dilation. The three sound processors were tested in random order with a single-blinded experimental design. Two conditions were performed at the same SNR: Condition 1, where the speech level was designed to saturate the PP but not the P3SP, and condition 2, where the overall sound level was decreased relative to condition 1 to reduce saturation artifacts. RESULTS: The P3SP led to higher speech intelligibility than the PP in both conditions, while the performance with the P3 did not differ from the performance with the PP and the P3SP. Pupil dilations were analyzed in terms of both peak pupil dilation (PPD) and overall pupil dilation via growth curve analysis (GCA). In condition 1, a significantly lower PPD, indicating a decrease in listening effort, was obtained with the P3SP relative to the PP. The PPD obtained with the P3 did not differ from the PPD obtained with the other two sound processors. In condition 2, no difference in PPD was observed across the three processors. The GCA revealed that the overall pupil dilation was significantly lower, in both conditions, with both the P3SP and the P3 relative to the PP, and, in condition 1, also with the P3SP relative to the P3. CONCLUSIONS: The overall effort to process a moderate to loud speech signal was significantly reduced by using a sound processor with a higher MFO (P3SP and P3), as a consequence of fewer saturation artifacts. These findings suggest that sound processors with a higher MFO may help BAHS users in their everyday listening scenarios, in particular in noisy environments, by improving sound quality and, thus, decreasing the amount of cognitive resources utilized to process incoming speech sounds.

The bone conduction implant - a review and 1-year follow-up.

Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices.Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience.Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm.Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband.Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.

[New options for rehabilitation of conductive hearing loss : Tests on normal-hearing subjects with simulated hearing loss]. / Neue Möglichkeiten der Rehabilitation bei Schallleitungsschwerhörigkeit : Tests an normalhörenden Probanden mit simulierter Schwerhörigkeit.

BACKGROUND: Bone conduction hearing aids can be worn as noninvasive devices using a clip or soft band that exerts pressure on the skin, or they can be surgically implanted. ADHEAR (MED-EL GmbH, Innsbruck, Austria) is a novel noninvasive bone conduction hearing aid that is attached behind the ear using an adhesive adapter and does not exert pressure on the skin. ADHEAR is indicated for patients with conductive hearing loss and normal inner ear function. The aim of this study was to evaluate the achievable hearing improvement with ADHEAR. MATERIALS AND METHODS: Twelve subjects with normal hearing participated in this study. To mimic conductive hearing loss, the participants' ear canals were occluded unilaterally with a foam ear plug. The resultant conductive hearing loss was assessed with pure tone air- and bone-conduction threshold audiometry. Hearing ability was tested with and without ADHEAR via free-field tone audiometry, number perception, and monosyllable perception, with the contralateral ear plugged depending on test requirements. RESULTS: Using ADHEAR, the free-field hearing threshold improved by 13.7 dB at 500 Hz, by 17.9 dB at 1 kHz, by 17.2 dB at 2 kHz, and by 9.8 dB at 4 kHz. In the higher frequencies, a significant pure-tone gain of 14.4 dB at 6 kHz and of 16.5 dB at 8 kHz was observed. Number perception with ADHEAR was mean 69.2% at 35 dB, 97.9% at 50 dB, 100% at 65 dB, and 100% at 80 dB. Monosyllable perception with the ADHEAR was mean 35.0% at 35 dB, 72.3% at 50 dB, 93.5% at 65 dB, and 98.8% at 80 dB. CONCLUSION: Hearing performance was significantly better with ADHEAR under all test conditions except those where maximum perception was already achieved without ADHEAR.

Long-Term Outcomes of Vibroplasty Coupler Implantations to Treat Mixed/Conductive Hearing Loss.

OBJECTIVE: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant. METHODS: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects. RESULTS: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively. CONCLUSION: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.

Development of a Novel Bone Conduction Verification Tool Using a Surface Microphone: Validation With Percutaneous Bone Conduction Users.

OBJECTIVES: To determine if a newly-designed, forehead-mounted surface microphone would yield equivalent estimates of audibility when compared to audibility measured with a skull simulator for adult bone conduction users. DESIGN: Data was analyzed using a within subjects, repeated measures design. There were two different sensors (skull simulator and surface microphone) measuring the same hearing aid programmed to the same settings for all subjects. We were looking for equivalent results. PATIENTS: Twenty-one adult percutaneous bone conduction users (12 females and 9 males) were recruited for this study. Mean age was 54.32 years with a standard deviation of 14.51 years. Nineteen of the subjects had conductive/mixed hearing loss and two had single-sided deafness. METHODS: To define audibility, we needed to establish two things: (1) in situ-level thresholds at each audiometric frequency in force (skull simulator) and in sound pressure level (SPL; surface microphone). Next, we measured the responses of the preprogrammed test device in force on the skull simulator and in SPL on the surface mic in response to pink noise at three input levels: 55, 65, and 75 dB SPL. The skull simulator responses were converted to real head force responses by means of an individual real head to coupler difference transform. Subtracting the real head force level thresholds from the real head force output of the test aid yielded the audibility for each audiometric frequency for the skull simulator. Subtracting the SPL thresholds from the surface microphone from the SPL output of the test aid yielded the audibility for each audiometric frequency for the surface microphone. The surface microphone was removed and retested to establish the test-retest reliability of the tool. RESULTS: We ran a 2 (sensor) × 3 (input level) × 10 (frequency) mixed analysis of variance to determine if there were any significant main effects and interactions. There was a significant three-way interaction, so we proceeded to explore our planned comparisons. There were 90 planned comparisons of interest, three at each frequency (3 × 10) for the three input levels (30 × 3). Therefore, to minimize a type 1 error associated with multiple comparisons, we adjusted alpha using the Holm-Bonferroni method. There were five comparisons that yielded significant differences between the skull simulator and surface microphone (test and retest) in the estimation of audibility. However, the mean difference in these effects was small at 3.3 dB. Both sensors yielded equivalent results for the majority of comparisons. CONCLUSIONS: Models of bone conduction devices that have intact skin cannot be measured with the skull simulator. This study is the first to present and evaluate a new tool for bone conduction verification. The surface microphone is capable of yielding equivalent audibility measurements as the skull simulator for percutaneous bone conduction users at multiple input levels. This device holds potential for measuring other bone conduction devices (Sentio, BoneBridge, Attract, Soft headband devices) that do not have a percutaneous implant.

Horizontal sound localisation accuracy in individuals with conductive hearing loss: effect of the bone conduction implant.

OBJECTIVE: The objective of this study is to quantify the effect of the Bone Conduction Implant (BCI) on sound localisation accuracy in subjects with conductive hearing loss (CHL). DESIGN: The subjects were tested in a horizontal sound localisation task in which localisation responses were objectively obtained by eye-tracking, in a prospective, cross-sectional design. The tests were performed unaided and unilaterally aided. The stimulus used had a spectrum similar to female speech and was presented at 63 and 73 dB SPL. The main outcome measure was the error index (EI), ranging from 0 to 1 (perfect to random performance). STUDY SAMPLE: Eleven subjects (aged 21-75 years, five females) with BCI participated in the study. Their mixed/conductive hearing loss was either unilateral (n = 5) or bilateral (n = 6). RESULTS: Three of five subjects (60%) with unilateral CHL, and four of six subjects (67%) with bilateral CHL showed significantly improved sound localisation when using a unilateral BCI (p < .05). For the subjects with bilateral CHL, a distinct linear relation between aided sound localisation and hearing thresholds in the non-implant ear existed at 73 dB SPL (18% decrease in the EI per 10 dB decrease in pure-tone average, r = 0.98, p < .001). CONCLUSIONS: Individuals with mixed/conductive hearing loss may benefit from a unilateral BCI in sound localisation.

Vibrant Soundbridge Implantation: Floating Mass Transducer Coupled with the Stapes Head and Embedded in Fat.

Subtotal petrosectomy may be performed for refractory chronic middle ear diseases, such as massive cholesteatoma or recurrent otitis media. It involves permanent obliteration of the operative cavity, thus precluding the chance to restore conductive hearing via traditional inertial ossicular prostheses. The Vibrant Soundbridge (VSB) is an alternative option for hearing rehabilitation. Vibrant energy is delivered into the inner ear via a floating mass transducer (FMT), which can be coupled with any part of the middle ear acoustic transmission structure. To restore the hearing of a young woman with cholesteatoma, we combined subtotal petrosectomy with obliteration of the cavity and VSB implantation with an FMT coupled to the stapes head. Two years of follow-up demonstrated excellent auditory rehabilitation, improved sound source localization ability, and a lower speech recognition threshold. This study showed that the FMT works well in an obliterated cavity, and the experience acquired through this successful exploration is worth disseminating.

An evaluation of the quality of evidence available to inform current bone conducting hearing device national policy.

OBJECTIVES: In 2016, NHS England published the commissioning policy on Bone Conducting Hearing Devices (BCHDs). This policy was informed by updated evidence on the clinical and cost-effectiveness of BCHDs as well as by the 2013 Bone Anchored Hearing Aid (BAHA) policy. Commissioning policies set the criteria for service delivery and therefore have a major impact on the care received by patients. It is important that stakeholders have a good appreciation of the available evidence informing policy, as this will promote engagement both with the policy and with future research leading on from the policy. In this article, we provide stakeholders with a transparent and pragmatic assessment of the quality of the body of evidence available to inform current BCHD national policy. METHOD: (i) A systematic review of the literature on BCHDs published since the development of the 2013 policy was performed in September 2016, adhering to PRISMA recommendations. The search terms used were as follows bone conduction; bone conducting; bone anchor; BAHA; Bone Anchored Hearing Aid; Bone Conducting Hearing Device; BCHD; Bone Conducting Hearing Implant; BCHI; Sophono; Bonebridge; Soundbite; Ponto; Hearing aid; implant; device; hearing device. Publications that could inform current BCHD policy were included. The quality of included articles was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. (ii) The quality of evidence referenced by the 2013 BAHA policy was assessed using the GRADE system. RESULTS: (i) Of the 2576 publications on BCHDs identified by the systematic search, 39 met the inclusion criteria for further analysis. Using the GRADE criteria, the quality of evidence was classified as of 'very low quality'. (ii) The 2013 BAHA policy was informed by 14 references. The GRADE system classifies the quality of evidence that informed the policy as of 'very low quality'. CONCLUSIONS: The GRADE system defines the body of evidence available to inform current national BCHD policy as of 'very low quality'. There is an urgent need for high-quality research to help make informed policy decisions about the care of patients with hearing loss. An (inter)national registry of BCHDs could address this need.