The impact of the Cochlear™ Osia® 2 System on patients with mixed or conductive hearing loss: A comparison with Cochlear™ Baha® Attract System outcomes.

OBJECTIVE: This prospective study assessed the efficacy of the Cochlear™ Osia® 2 System compared to the previous Baha® Attract System in patients with mixed or conductive hearing loss (MHL/CHL). METHODS: In this prospective case-control study, 10 patients (2 men and 8 women) with MHL/CHL were implanted with the Osia® 2 System. Their audiological outcomes were compared with 13 patients (2 men and 11 women) who had previously been implanted with the transcutaneous Baha® Attract system. We compared the complications and compliance of the two groups. Also, in the Osia 2 System group, subjective satisfaction was assessed using the Korean version of the International Outcome Inventory for Hearing Aids (K-IOI-HA) questionnaire and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. RESULTS: Complications such as poor magnetization, pain & infection, and abnormal noise were more common in the Baha Attract group, although not statistically significant. Also, the Osia 2 group exhibited better compliance. Subjective satisfaction was assessed using the K-IOI-HA and APHAB questionnaires with the Osia 2 group, revealing significantly improved scores in ease of communication, reverberation, background noise, and higher K-IOI-HA scores post-implantation. Postoperative-aided thresholds with both systems were significantly lower than preoperative-unaided thresholds, with the Osia 2 System demonstrating notably high satisfaction levels. Although both systems showed similar preoperative and postoperative word-recognition scores, the Osia 2 System provided greater audiological gain, especially at 2 kHz and 4 kHz frequencies. Additionally, the functional gain of both systems was comparable across all frequencies. CONCLUSIONS: The Osia 2 System demonstrated high subjective satisfaction and improved audiological outcomes compared to the Baha Attract system in patients with conductive or mixed hearing loss. Its superior audiological gain, particularly at critical frequencies, along with better compliance, suggests it as a favorable option for this patient population.

The Merits of Bilateral Application of Middle Ear Implants in Patients With Bilateral Conductive and/or Mixed Hearing Loss.

This study investigated sound localization abilities in patients with bilateral conductive and/or mixed hearing loss (BCHL) when listening with either one or two middle ear implants (MEIs). Sound localization was measured by asking patients to point as quickly and accurately as possible with a head-mounted LED in the perceived sound direction. Loudspeakers, positioned around the listener within a range of +73°/-73° in the horizontal plane, were not visible to the patients. Broadband (500 Hz-20 kHz) noise bursts (150 ms), roved over a 20-dB range in 10 dB steps was presented. MEIs stimulate the ipsilateral cochlea only and therefore the localization response was not affected by crosstalk. Sound localization was better with bilateral MEIs compared with the unilateral left and unilateral right conditions. Good sound localization performance was found in the bilaterally aided hearing condition in four patients. In two patients, localization abilities equaled normal hearing performance. Interestingly, in the unaided condition, when both devices were turned off, subjects could still localize the stimuli presented at the highest sound level. Comparison with data of patients implanted bilaterally with bone-conduction devices, demonstrated that localization abilities with MEIs were superior. The measurements demonstrate that patients with BCHL, using remnant binaural cues in the unaided condition, are able to process binaural cues when listening with bilateral MEIs. We conclude that implantation with two MEIs, each stimulating only the ipsilateral cochlea, without crosstalk to the contralateral cochlea, can result in good sound localization abilities, and that this topic needs further investigation.

Simulator Verification Is Potentially Beneficial for the Fitting of Softband Bone Conduction Hearing Devices in Young Children.

HYPOTHESIS: The current study employed a skull-simulator verification method to assess whether the output of softband bone conduction hearing devices (BCHDs) at the manufacturer's default settings deviated widely from the target determined by the fitting formula. BACKGROUND: Real ear analysis is utilized for the verification of the fitting of air conduction hearing devices (ACHDs) in a variety of institutions. This procedure, however, has not been used in the fitting of BCHDs, largely due to the difficulty of testing the output of these devices to temporal bones. Despite the availability of skull simulators, they have not been utilized clinically to measure BCHD output. MATERIALS AND METHODS: This prospective, single-center study enrolled 42 subjects, aged 3 months to 10 years, with microtia-atresia-associated mild-to-severe bilateral conductive hearing loss. Hearing sensitivity was evaluated behaviorally by pure tone audiometry (PTA) in 22 subjects 4 years or older (the PTA group), and by auditory brainstem response (ABR) in 20 subjects younger than 4 years (the ABR group). Following 6 months of subjects wearing the prescribed softband BCHDs, their dial level (DL) thresholds were reassessed while using their own BCHDs, configured with zero gain across all frequencies, functioning solely as a bone vibrator. These DL thresholds were inputted into the fitting formula, desired sensation level-bone conduction devices (DSL-BCD) for children, to obtain the target values of BCHD output. The simulator output of the BCHD programmed at the manufacturer's default setting was measured in response to speech presented at 55, 65, and 80 dB SPL, followed by gain adjustment based on the differences between the simulator output and the target. Aided speech intelligibility index (SII) was measured before and after the gain adjustment. RESULTS: The softband BCHDs at the manufacturer's settings generally had lower output than the prescribed target values. This difference was larger at low frequencies and low levels. Across the 12 points tested (four frequencies from 500 to 4000 Hz multiplied by three levels), 22 (52.3%) and 42 (100%) BCHDs had deviations of +7 and +5 dB, respectively, at one point or more. The gain adjustments reduced the deviation and improved the SII values at the two lower levels of speech presented. CONCLUSION: The simulator output of softband bone conduction hearing devices (BCHDs) with the manufacturer's settings may exhibit significant deviations from the formula. Objective output verification should be considered a beneficial step in BCHD fitting and is recommended when applicable.

Examining Force Level Output of Skin-Drive Bone Conduction Hearing Devices in Adults With Simulated Conductive Hearing Loss.

PURPOSE: Bone conduction hearing devices (BCDs) that deliver sound across the skin (i.e., transcutaneous) are suitable for some individuals who have conductive or mixed hearing losses. Prescriptive targets for percutaneous devices are available, for example, from the Desired Sensation Level-Bone Conduction Hearing Device (DSL-BCD) algorithm. These targets, however, may require modification for use with transcutaneous BCDs. The current study investigated three key variables that may inform target modification: (a) comparison of thresholds measured using an audiometric bone conduction (BC) transducer versus transcutaneous BCDs that offer in situ threshold measurement, (b) transcutaneous BCD default force level outputs versus recommended DSL percutaneous BC targets, and (c) the preferred listening levels (PLLs) of adults wearing transcutaneous BCDs in a laboratory setting. METHOD: Bilateral conductive hearing loss was simulated in 20 normal-hearing adults via earplugs. Thresholds were measured using a B-71 BC transducer and two commercially available BCDs coupled to a soft headband. DSL percutaneous BC targets were generated, and PLLs were obtained for a 60-dB SPL speech stimulus. Force level outputs were measured using a skull simulator on the Audioscan Verifit2 at the hearing aids' default settings and at the participants' PLL for each device. RESULTS: On average, audiometric BC thresholds were significantly better than those measured in situ with each BCD. PLLs were similar to prescribed targets for one device with the smoother response shape and agreed in the high frequencies for both devices. CONCLUSIONS: In situ thresholds are significantly higher than audiometric BC thresholds, suggesting that device-based in situ measurement more accurately accounts for the signal transmission from transcutaneous BCDs. PLLs differed from the percutaneous targets and varied between devices, which may indicate that either target modifications or manipulations of device frequency response shaping are needed to approximate PLL with transcutaneous BCD devices.

Binaural hearing in monaural conductive or mixed hearing loss fitted with unilateral Bonebridge.

Objective: To determine the benefits of binaural hearing rehabilitation in patients with monaural conductive or mixed hearing loss treated with a unilateral bone conduction implant (BCI). Methods: This monocentric study includes 7 patients with monaural conductive or mixed hearing loss who underwent surgical implantation of a unilateral BCI (Bonebridge, Med-El). An ITA Matrix test was performed by each patient included in the study - without and with the BCI and in three different settings - to determine the summation effect, squelch effect and head shadow effect. Subjective hearing benefits were assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Results: The difference in signal to noise ratio of patients without and with BCI was 0.79 dB in the summation setting (p < 0.05), 4.62 dB in the head shadow setting (p < 0.05) and 1.53 dB (p = 0.063) in the squelch setting. The APHAB questionnaire revealed a subjective discomfort in the presence of unexpected sounds in patients using a unilateral BCI (aversiveness score) compared to the same environmental situations without BCI, with a mean discomfort score of 69.00% (SD ± 21.24%) with monaural BCI versus 25.67% (SD ± 16.70%) without BCI (difference: -43.33%, p < 0.05). In terms of global score, patients wearing a unilateral Bonebridge implant did not show any significant differences compared to those without hearing aid (difference: -4.00%, p = 0.310). Conclusions: Our study shows that the use of a unilateral BCI in patients affected by monaural conductive or mixed hearing loss can improve speech perception under noise conditions due to the summation effect and to the decrease of the head shadow effect. However, since monaural BCIs might lead to discomfort under noise conditions in some subjects, a pre-operative assessment of the possible individual benefit of a monaural BCI should be carried out in patients affected by unilateral conductive or mixed hearing loss in order to investigate the possible additional effect of the fitting of hearing aids.

Bone Conduction Implants: Comparative of Audiometric Results and Quality-of-Life Bonebridge® versus Osia®.

INTRODUCTION: Bone conduction implants have been indicated for patients with conductive hearing loss, mixed hearing loss, and even profound unilateral sensorineural hearing loss. With the introduction of Bonebridge®, new transcutaneous implant options emerged. The latest is Osia®, a direct-drive variant or active systems, where the implant directly generates and applies vibration to the bone. MATERIALS AND METHODS: Retrospective study of two cohorts of patients treated with active bone conduction implants at a single center, one with the Bonebridge® device and the other with Osia®. OUTCOMES: Fourteen patients were included, seven in each group (n = 14). The Bonebridge® group showed an average hearing gain in tonal intelligibility thresholds of 32.43 ± 21.39 dB and a gain in the average intelligibility threshold (with 50% discrimination) of 26.29 ± 19.10 dB. In the Osia® group, there was a gain in average tonal thresholds of 41.49 ± 14.16 dB and 23.72 ± 6.98 dB in average intelligibility thresholds. Both devices contributed to improvements in patients' quality of life, as assessed with APHAB in all the variables studied in the test. Both devices offer rehabilitation for hearing loss as an alternative to hearing aids. The Osia® system shows statistically significant (p < 0.05) improvements in mid and high frequencies, but Bonebridge® slightly outperforms in speech understanding at 50%. Differences in average tonal thresholds and quality of life are not statistically significant. CONCLUSIONS: While auditory improvement is observed postimplantation, other aspects, such as intelligibility thresholds and quality of life, lack statistical significance. Given the limited experience with Osia® and the small sample size, the choice of the device should be personalized. Although the literature is inconsistent due to small sample sizes and variable approaches, some studies suggest potential advantages of the Osia® system, especially in speech comprehension in different environments and greater hearing gain compared to Bonebridge®.

Surgical Outcomes of Modified Technique for Transcutaneous Bone Conduction Hearing Aid Implantation.

OBJECTIVE: To detail a modified surgical technique for implantation of the Osia 2 Bone Conduction Hearing Aid (BCHA) system and to assess intra- and postoperative outcomes of this technique. METHODS: A retrospective review was performed for cases undergoing implantation of an Osia 2 BCHA at a tertiary academic medical center. Modifications were made to the surgical procedure including: horizontal or curvilinear incisions, placement of the osseointegrated screw slightly superior to the plane of the external auditory canal, and double layer wound closure. Data regarding outcomes including demographics, incision type, surgical time, drilling requirements, and complications were collected using the electronic medical record. RESULTS: A total of twenty-eight cases were evaluated with 57.1% and 42.9% utilizing horizontal and curved incisions, respectively. The median age for recipients was 43.1 years with six pediatric cases included in the study. Median operative time was 58 min (43-126 min). The majority of cases required minimal (60.7%) or no drilling (28.6%) with a significant increase in operative time for those requiring moderate drilling versus minimal to no drilling (F = 8.02, p = 0.002). There were no intraoperative complications. One (3.6%) postoperative seroma occurred which resolved with conservative management. CONCLUSION: The proposed modified surgical technique is a safe and effective method for implantation of the transcutaneous BCHA system with a low complication rate. Keys include incision design, implant placement, and two-layered closure to minimize wound tension. These modifications can improve ease of the procedure and reduce operative time. These techniques also appear to be applicable to the pediatric population. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:2401-2404, 2024.

Precise selection of bone conduction hearing devices for congenital malformation of the middle and outer ear (CMMOE).

Background: No selection criteria for the four bone conduction hearing devices yet.Aims/Objectives: To compare effectiveness of four bone conduction hearing devices in patients with bilateral Congenital Malformation of the Middle and Outer Ear (CMMOE).Material and Methods: 24 Patients (25 ears) were divided into five groups: 1) Bone Anchored Hearing Aid softband (BAHA-s), 2) BAHA implant (BAHA-i nested within group 1), 3) Vibration Sound Bridge implant (VSB-i), 4) Bone Bridge implant (BB-i), and 5) Bone Conduction Hearing Aid softband (BCHA-s). One patient implanted VSB and BB. Auditory parameters were compared: 1. Communication, 2. Average Air Conduction Thresholds (ACT) of pure tone, 3. Sentence Recognition Scores in quiet (SRS-q) and noisy (SRS-n) settings. The one-way analysis of variance (ANOVA) were employed to compare the differences in ACT and SRS-q/n among the groups, a statistical significance level of P < 0.05 was applied.Results: After hearing aid usage, all 24 patients (25 ears) reached or approached the normal in communication (i.e. from difficult to smooth), average ACT and SRS-q/SRS-n (no difference among groups, p > 0 .05). However, there was the difference in the optimal frequency of ACT and the absolute value of SRS-q/SRS-n for VSB/BAHA implants was higher than that for BB and BAHA softband.Conclusions and Significance: The precise selection of the four hearing devices mainly depends on patient's hearing level, the optimal frequency of ACT and absolute values of SRS-q/SRS-n.

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 Oticon Ponto System in Adults With Severe-to-Profound and Mixed Hearing Loss: Audiologic Outcomes and Patient Satisfaction.

OBJECTIVE: To measure audiologic outcomes and self-assessed satisfaction with the Ponto system in a group of patients who had severe to profound and mixed hearing loss. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Sixteen patients aged 21 to 74 years with severe-to-profound and mixed hearing loss (bone conduction thresholds, ≥45 dB HL). INTERVENTIONS: Ponto implant surgery. MAIN OUTCOME MEASURES: Pure-tone audiometry, free-field hearing thresholds, effective gain, word recognition score in quiet, and speech reception threshold (SRT) in noise were assessed. Patient-reported outcomes were collected using the Clinical Global Impression Scale, Glasgow Benefit Inventory, and Abbreviated Profile of Hearing Aid Benefit. Information concerning any medical complications was also gathered. RESULTS: Both word recognition score and SRT were significantly better after 12 months compared with before surgery. At normal speech level (65 dB SPL), 12 of 16 users had speech discrimination ≥70%. However, at the 12-month follow-up, the average effective gain was -6.2 dB. In general, the self-report outcomes showed good satisfaction in most patients. Postoperatively, skin complications were noted in six patients, of whom two underwent reoperation. All patients were still using the Ponto after an average observation time of 2.7 years. CONCLUSION: Although skin complications were not uncommon, the Ponto system seems to be an effective method of improving hearing performance and provides subjective satisfaction in real-life situations in patients with severe-to-profound and mixed hearing loss. However, considering the significantly increased bone conduction thresholds and the risk of their further deterioration, long-term follow-up is still needed.

The Baha® Attract System Implantations Significantly Improve the Quality of Life of Hearing-Impaired Patients in Long-Term Observations.

BACKGROUND: The aim of this study was to assess the impact of the Baha® Attract system implantation on the quality of life of hearing-impaired patients, who were qualified for surgery due to various audiological indications. METHODS: A total of 96 patients implanted with the Baha® Attract system were asked to fill in the set of questionnaires: the Glasgow Benefit Inventory, the Abbreviated Profile of Hearing-Aid Benefit, and the BAHA Aesthetic, Hygiene, and Use. Totally 79 patients responded and were then analyzed. Patients were divided into 4 groups: A: with bilateral mixed or conductive hearing loss, B: with single-sided deafness, C: with unilateral mixed or conductive hearing loss, and D: others. RESULTS: There was a significant improvement in quality of life measured by the Glasgow Benefit Inventory in all the analyzed groups, with a mean total score of 29.4 points (P < .001). Similarly, the evaluation by the Abbreviated Profile of Hearing Aid Benefit questionnaire showed a significant improvement in terms of the global score in all the analyzed groups, with a mean gain of 38.6% (P < .001). There were no differences between the groups. More than 90% of patients found the Baha® Attract system easy to place on their heads and maintain good hygiene. Of all the implant users, 81% were satisfied with the final aesthetic effect. CONCLUSION: The implantation of the Baha® Attract system significantly improves the quality of life of hearing-impaired patients in all subjec- tive scales used. The system is effective for all audiological indications when strictly adhered to. The majority of patients are very satisfied with the aesthetic, hygienic, and utility aspects of the device.

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.

Efficient Bone Conduction Hearing Device With a Novel Piezoelectric Transducer Using Skin as an Electrode.

OBJECTIVE: Bone conduction hearing aids are the only non-surgical devices used for conductive hearing loss. However, they are impractical for lifelong use since they require close contact of the transducer with the head skin, causing skin erosion and discomfort. Bone conduction hearing implants and active middle ear implants do not present these issues; however, they require surgery and can sometimes cause issues in the skin surrounding the devices. This study aimed to develop a new bone conduction hearing device that does not exert pressure on the skin or require surgery. METHODS: Our device modified a piezoelectric element by using the skin of a pinna as one of the two electrodes of a conventional piezoelectric device. We compared the sound transmission of a speaker, a conventional piezoelectric device, or the new device to the Guinea pig cochlea, a physiological sound transducer to the auditory nerve, in normal and air-conductive hearing loss conditions. RESULTS: The novel device transmitted sound to the cochlea even after causing air-conductive hearing loss. Its bone conduction was more efficient than the speaker and the conventional piezoelectric device. CONCLUSION: We developed a novel type of bone conduction device that efficiently transmits sound to the cochlea by skipping the external auditory canal, tympanic membrane, and middle ear ossicles. This device does not exert pressure on the skin that can result in skin damage, an adverse effect of a conventional bone conduction hearing aid. SIGNIFICANCE: Our novel hearing device can be used as a substitute for current bone-conduction hearing devices.

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.

Auricular reconstruction using Medpor combined with different hearing rehabilitation approaches for microtia.

BACKGROUND: Congenital microtia-atresia affects patients in two specific ways: severe conductive hearing loss and difficulty in integrating into social environments due to auricle malformation. AIMS/OBJECTIVES: To investigate the safety and efficacy of single-stage auricular reconstruction and hearing rehabilitation in children with microtia and external auditory canal atresia. MATERIAL AND METHODS: From January 2016 to December 2019, we included 32 patients with microtia and external canal atresia who received auricle reconstruction with high-density polyethylene (Medpor) framework and three different hearing rehabilitation approaches at the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Twenty patients underwent the traditional external auditory canal and middle ear repair (EACR), eight patients were implanted with Bonebridge (BB) devices, and four patients were implanted with bone-anchored hearing aid (BAHA) in one stage. Postoperative changes in auricle morphology and hearing and speech recognition and occurrence of complications were evaluated. RESULTS: After 6-24 months of follow-up, the auricle shape recovered well in all three groups, and the average score of 14 fine structures in the auricle was 9.43 (EACR), 10.67 (BB), and 9.75 (BAHA) points. The average score of auricle symmetry was 6.83 (EACR), 6.00 (BB), and 6.44 (BAHA) points. No significant differences in auricle shape were observed among the three groups (p > .05). After surgery, the average hearing improvement in the BB group was 43.33 dB, and the average speech recognition threshold declined to 42.28 dB. In the BAHA group, the average hearing improvement was 35 dB, and the average speech recognition threshold declined to 33.5 dB, similar to that of the BB group. However, in the EACR group, the average hearing improvement was only 4.13 dB, and the average speech recognition threshold declined to 11.36 dB. No vertigo, tinnitus, cerebrospinal fluid leakage, facial nerve paralysis, osseointegration failure, and other complications occurred in all the patients. In the EACR group, auricle stent fracture, ear canal restenosis, and canal atresia occurred in one patient each. In the BAHA group, two patients developed local ear infections. CONCLUSIONS AND SIGNIFICANCE: The procedure of single-stage auricular reconstruction and hearing rehabilitation for microtia is feasible and effective. The appropriate method of hearing reconstruction should be determined by evaluating the development of the inner and middle ear of the patients. For those patients with poor development of the mastoid and ossicular chain, hearing aid devices are recommended to achieve a stable and significant hearing effect.

Long term cutaneous complications related to bone conduction hearing implants. A retrospective study (2004-2018).

OBJECTIVE: The aim of this study was to establish the frequency of cutaneous complications due to surgically implanted bone conduction hearing aids in recipients treated at a tertiary otolaryngology center. Additionally, based on the literature review, we propose a scale to standardize the report of cutaneous reactions related to transcutaneous systems to objectify future studies. METHODS: A retrospective chart review was conducted for patients who were implanted with bone conduction hearing systems between 2004 and 2018. Patients with minimum follow up of 6 months were included. Patient demographics, surgical characteristics and clinical course was analyzed by number and skin reactions. Transcutaneous and percutaneous systems were analyzed separately. The study was approved by the local IRB. RESULTS: A total of 104 devices were implanted on 88 patients with an average follow up of 4.04 (range of 0.5 - 10 years). Out of the total of patients, 49 (55.7%) developed at least one episode of inflammatory/infectious skin reaction at surgical incision site. A total of 148 episodes of local infections during the entire follow-up period were registered, mostly mild in severity with no triggering factors identified. The majority of the initial episodes of infection occurred within the first 3 years of follow-up. Out of the total of patients, 47 (53.4%) reported pain at the surgical site at some point throughout follow-up, not associated with clinically evident infection. CONCLUSION: The incidence of skin complications in our series seemed higher compared to previous reports. Minor complications were the most common and responded well to topical treatment. No triggering factors were identified as the cause of the infections, nor to explain the frequency or the severity of such an adverse reaction. Isolated pain was present in the majority of patients with conductive hearing devices, even without signs of active infection. Due to its high incidence it should be assessed in all patients that receive an implant. Based on a search of the literature, a scale to standardize cutaneous complications of transcutaneous implants was undertaken, but further studies are needed to validate such a scale.

3D Printing of a BAHA Protective Cap.

Mechanical feedback is one of the most common difficulties encountered when fitting hearing aids for toddlers and young children. We described the use of 3D printing to tailor a protective cap for a toddler with bilateral microtia/canal atresia to facilitate bone-anchoring hearing aid use.

Bone-conduction hearing aid is effective in congenital oval window atresia.

BACKGROUND: Implantable bone-conduction hearing aids (BCHA) are effective in patients with congenital ear malformations.However, there is no large sample study to verify the efficacy of Bonebridge in patients with congenital oval window atresia. OBJECTIVES: To investigate efficiency of implantable bone-conduction hearing aids in Mandarin-speaking patients with congenital oval window atresia. MATERIAL AND METHODS: We retrospectively analyzed 15 patients, who were confirmed with either unilateral or bilateral congenital oval window atresia by temporal bone CT. All patients were implanted with a bone-conduction hearing device between July 2016 and July 2019 at Beijing Tongren Hospital, Capital Medical University. Pure tone audiometry (PTA), air-bone gap (ABG), speech discrimination scores (SDSs), and hearing thresholds were performed. RESULTS: Postoperative complications including facial paralysis were particularly rare. Unaided mean sound field threshold was 62.2 ± 10.5 dBHL and that with implantable bone-conduction hearing aids was 39.1 ± 13.2 dBHL (p < 0.01). The mean speech discrimination scores improved greatly (p < 0.01), specifically with regard to sentence and disyllabic words. CONCLUSIONS: Patients with congenital oval window atresia often show moderate to severe conductive hearing loss. Implantable bone-conduction hearing aids are considerably safe and stable for hearing rehabilitation. It is a novel treatment modality for Mandarin-speaking patients with congenital oval window atresia.

ADHEAR device in bone conduction audiometry.

ADHEAR is a bone conduction hearing aid that uses an adhesive skin adapter. In the current study, the use of ADHEAR as an audiometric bone stimulator was investigated in normal-hearing subjects by comparing it to the standard Radio-Ear B71. Bone conduction thresholds of 15 normal-hearing subjects (aged 21-36 years) were measured four times in a randomized order, twice with the B71 and twice with the ADHEAR. There were no significant differences in test-retest reliability between the two devices. Subjectively rated comfort was better for the ADHEAR. The development of a specific audiometric adhesive bone stimulator may be warranted.