相关临床试验
5
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
2
40.0%
招募中
2
40.0%
终止
1
20.0%
暂无批准数据
- The global ENT devices market was valued at USD 24.89 billion in 2025 and is projected to reach USD 44.91 billion by 2035, growing at a CAGR of 6.08%. - Hearing aids remain the largest product segment at approximately 32.40% share, while surgical ENT devices are the fastest-growing at roughly 6.52% CAGR. - North America held the largest regional share at approximately 37.60% in 2025, with Asia-Pacific emerging as the fastest-growing region at about 6.59% CAGR. - FDA over-the-counter hearing aid reform is expected to make an estimated 28 to 38 million Americans with untreated mild-to-moderate hearing loss newly reachable through consumer channels.
- Sensorion's Data Monitoring Committee found no safety concerns and approved continuation of the Audiogene Phase 1/2 trial for SENS-501 gene therapy targeting OTOF gene mutations. - Two of three patients in the second cohort demonstrated early hearing improvements by Month 3, with behavioral thresholds of approximately 60-70 dB HL at best-performing frequencies. - The trial targets infants aged 6-31 months with otoferlin-mediated congenital deafness, aiming to restore hearing during critical brain plasticity periods before cochlear implantation. - SENS-501 uses AAV viral vector technology to deliver functional OTOF gene copies directly to inner ear hair cells, representing a potential breakthrough for genetic hearing loss treatment.
- Cochlear Limited announced FDA approval of the Nucleus Nexa System, the world's first smart cochlear implant featuring upgradeable firmware that enables recipients to access future innovations through both implant and sound processor updates. - The new system includes the smallest and lightest sound processor with all-day battery life, featuring Dynamic Power Management algorithm and internal memory for secure storage of hearing settings. - This breakthrough addresses the limitation that previously required recipients to replace external components to access new technology, potentially enhancing long-term user experience for the 430 million people worldwide living with disabling hearing loss.
- Sensorion has enrolled the final patient in its NOTOXIS Phase 2a trial evaluating SENS-401 for preventing hearing loss caused by cisplatin chemotherapy, with 47 patients randomized across treatment and control groups. - Preliminary results from 16 patients suggest SENS-401 may provide otoprotective effects at cisplatin doses exceeding 300 mg/m², addressing a serious side effect that affects 40-60% of cancer patients receiving platinum-based chemotherapy. - The oral small molecule therapy is administered before, during, and after chemotherapy treatment, with topline results from the full study expected by the end of 2025.
